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Study Objectives Oncological home-hospitalization might be a patient-centred, cost-effective approach to deal wiht the current challenges in cancer healthcare. The primary aim of this clinical trial is to evaluate patient-reported quality of life of patients receiving (partial) oncological home-hospitalization and to compare this outcome with patients receiving standard ambulatory hospital care. Secondary endpoints that will be evaluated and compared between both randomized groups are: Quality of life related endpoints (i.e. distress, depression \& anxiety and general health-related quality of life); Costs; Safety; patients' reported Satisfaction \& Preferences and Efficiency for the hospital day care unit. Conditions: Cancer Intervention / Treatment: PROCEDURE: (partial) oncological home-hospitalization Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Starting new oncological treatment at the outpatient hospital * ECOG <= 2 * Living within 30 minutes of drive from the hospital Exclusion Criteria: * Important comorbidity (ECOG > 2) * Life expectancy < 6 months * Simultaneous treatment with radiotherapy * Taking part in clinical trial with any Investigational Medicinal Product * Language barriers or communication difficulties * Problematic venous access

NCT_ID NCT03668275

Study_NameEvaluating Quality and Cost of (Partial) Oncological Home-Hospitalization

Study Objectives This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye. Conditions: Recurrent Uveal Melanoma, Stage III Uveal Melanoma AJCC v7, Stage IIIA Uveal Melanoma AJCC v7, Stage IIIB Uveal Melanoma AJCC v7, Stage IIIC Uveal Melanoma AJCC v7, Stage IV Uveal Melanoma AJCC v7 Intervention / Treatment: DRUG: Cabozantinib S-malate, DRUG: Dacarbazine, OTHER: Laboratory Biomarker Analysis, DRUG: Temozolomide Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed uveal melanoma that is metastatic or unresectable; if histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma; pathologic confirmation of diagnosis will be performed at the participating site * Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI) * Prior systemic therapies allowed, except for those treatments directed toward, or with activity against, c-Met or vascular endothelial growth factor/receptor (VEGF/R), and the chemotherapy agents temozolomide and dacarbazine; prior treatment must have been no earlier than 3 weeks prior to starting treatment with cabozantinib with exceptions noted below and the following: at least 4 weeks since prior hepatic infusion or at least 2 weeks since radiation therapy * No cytotoxic chemotherapy including investigational cytotoxic chemotherapy or biologic agents (e.g., cytokines or antibodies) within the last 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment; at least 6 weeks must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody; patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator * No prior radiation therapy within the last 4 weeks, except as below * To the thoracic cavity, abdomen, or pelvis within 12 weeks before the first dose of study treatment, or has ongoing complications, or is without complete recovery to < grade 1 toxicity * To bone or brain metastasis within 14 days before the first dose of study treatment * To any other site(s) within 28 days before the first dose of study treatment * Prior radiation treatment may have included no more than 3000 centigray (cGy) to fields including substantial bone marrow * No prior radionuclide treatment within 6 weeks of the first dose of study treatment * No prior treatment with a small molecule kinase inhibitor or a hormonal therapy within 14 days or 5 half-lives (whichever is longer) * No concomitant anti-cancer therapy unless specified above * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) * A corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the patient meets eligibility in this regard * Common Terminology Criteria for Adverse Events (CTCAE) recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) * No active brain metastases or epidural disease; patients with brain metastases previously treated with whole brain radiation or radiosurgery or patients with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 12 weeks before starting study treatment; baseline brain imaging with contrast-enhanced CT or MRI scans for patients with known brain metastases is required to confirm eligibility * No clinically significant gastrointestinal bleeding within 24 weeks before the first dose of study treatment * No hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 12 weeks before the first dose of study treatment * No signs indicative of pulmonary hemorrhage within 12 weeks before the first dose of study treatment * No prior radiographic evidence of cavitating pulmonary lesion(s) * No tumor in contact with, invading or encasing any major blood vessels * No evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of treatment * The patient may not have uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Cardiovascular disorders including: * Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening * Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment * Any history of congenital long QT syndrome * Any of the following within 24 weeks before the first dose of study treatment: * Unstable angina pectoris * Clinically-significant cardiac arrhythmias * Stroke (including transient ischemic attack [TIA], or other ischemic event) * Myocardial infarction * Thromboembolic event requiring therapeutic anticoagulation (Note: patients with a venous filter [e.g. vena cava filter] are not eligible for this study) * Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including: * Any of the following within 28 days before the first dose of study treatment * Intra-abdominal tumor/metastases invading GI mucosa * Active peptic ulcer disease * Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis * Malabsorption syndrome * Any of the following within 24 weeks before the first dose of study treatment: * Abdominal fistula * Gastrointestinal perforation * Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 24 weeks before the first dose of study treatment * Bowel obstruction or gastric outlet obstruction * Other clinically significant disorders such as: * Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment * History of organ transplant * Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment * History of major surgery as follows: * Major surgery in past 8 weeks of the first dose of cabozantinib if there were no wound healing complications or within 24 weeks of the first dose of cabozantinib if there were wound complications * Minor surgery within 4 weeks of the first dose of cabozantinib if there were no wound healing complications or within 12 weeks of the first dose of cabozantinib if there were wound complications * In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery * Active infection requiring systemic treatment within 28 days before the first dose of study treatment * No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of Torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with cabozantinib: * Boceprevir * Indinavir * Nelfinavir * Lopinavir/ritonavir * Saquinavir * Telaprevir * Ritonavir * Clarithromycin * Conivaptan * Itraconazole * Ketoconazole * Mibefradil * Nefazodone * Posaconazole * Voriconazole * Telithromycin * Drugs with possible or conditional risk of torsades should be used with caution knowing that cabozantinib could prolong the QT interval * Patients who are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test within 16 days prior to registration; women of child-bearing potential include: * Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months) * Women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35m IU/mL * Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, temozolomide and dacarbazine * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Total bilirubin =< 1.5 × upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5.0 × institutional upper limit of normal (for patients with metastases); AST (SGOT)/ALT (SGPT) =< 2.5 × institutional upper limit of normal (for patients without metastases) * Serum creatinine =< 1.5 × ULN, OR calculated creatinine clearance >= 30 mL/minute (modified Cockcroft and Gault formula) * Hemoglobin >= 9 g/dL * Serum albumin >= 2.8 g/dL * Urine protein/creatinine ratio (UPCR) =< 1; if urine/protein creatinine (UPC) >= 1, then a 24-hour urine protein must be assessed; eligible patients must have a 24-hour urine protein value < 1 g/L * Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH however free T4 and free thyroxine index (FTI) are normal and patient is clinically euthyroid, patient is eligible * Prothrombin time (PT)/international normalized ratio (INR) must be =< 1.2 x the laboratory ULN * No clinical or radiographic evidence of pancreatitis

NCT_ID NCT01835145

Study_NameCabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery

Study Objectives This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Conditions: Childhood Acute Promyelocytic Leukemia With PML-RARA, Myeloid Neoplasm Intervention / Treatment: DRUG: Arsenic Trioxide, DRUG: Cytarabine, OTHER: Diagnostic Laboratory Biomarker Analysis, DRUG: Idarubicin, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Mitoxantrone Hydrochloride, DRUG: Tretinoin Location: Canada, United States, Puerto Rico Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must be newly diagnosed with a clinical diagnosis of acute promyelocytic leukemia initially by morphology (bone marrow or peripheral blood); bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted; APL is considered a hematological emergency and treatment should be initiated as quickly as possible without waiting for molecular or cytogenetic/fluorescence in situ hybridization (FISH) confirmation; for patients who are unable to begin receiving ATRA in a timely manner following a presumed diagnosis of APL, consideration should be given to initiating ATRA and proceeding with treatment outside of the AAML0631 protocol; if the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR to be eligible; patients without evidence of APL by bone marrow or peripheral blood morphology but with isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible provided that the t(15;17) translocation is documented on either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment; in this situation, touch preps from the tumor site can be evaluated by FISH with PML-RARA probes; NOTE: A lumbar puncture is not required to be enrolled on study; if the diagnosis of APL is known or suspected, extreme caution must be exercised in performing a lumbar puncture during active coagulopathy; in addition a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma if central nervous system (CNS) disease is suspected or proven; if CNS disease is documented, patients are still eligible * No minimal performance status criteria * The patient must not have received systemic definitive treatment for APL or other suspected leukemia, including cytotoxic chemotherapy, retinoids, or arsenic; prior therapy with corticosteroids, hydroxyurea, or leukopheresis will not exclude the patient; if a patient received intrathecal cytarabine prior to the diagnosis of APL being known, the patient will still be eligible as long as they meet all other eligibility requirements Exclusion Criteria: * Pregnant women or nursing mothers are excluded; treatment under this protocol would expose an unborn child to significant risks; patients should not be pregnant or plan to become pregnant while on treatment; women and men of reproductive potential should agree to use an effective means of birth control; there is an extremely high risk of fetal malformation if pregnancy occurs while on ATRA in any amount even for short periods * Patients with a pre-existing prolonged QT Syndrome will not be eligible for this protocol due to the use of arsenic trioxide which can prolong the QT interval

NCT_ID NCT00866918

Study_NameCombination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

Study Objectives This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Conditions: Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer Intervention / Treatment: DRUG: erlotinib hydrochloride, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic (M1); patients with unresectable primary tumor (but M0) are also eligible; patients who have undergone a prior nephrectomy should have histologic confirmation of the metastatic nature of at least one distant site of disease * Patients must have available and be willing to submit representative slides for central pathology review; these must be sent within 28 days of registration; failure to submit these materials will make the patient ineligible for this study * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; soft tissue disease that has been radiated in the 2 months prior to registration is not assessable as measurable disease; soft tissue disease within a prior radiation field that was radiated greater than 2 months prior to registration must have progressed to be considered assessable, and patients also must have measurable disease outside of the irradiated field; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration * Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery * Patients with a history of brain metastases or who currently have treated or untreated brain metastases are not eligible; patients with clinical evidence of brain metastases must have a brain CT or MRI negative for metastatic disease within 56 days prior to registration * Patients must have available and be willing to submit archived tumor tissue that will yield sixteen 5 micron unstained slides for molecular correlative studies related to the EGFR and vHL pathways * Patients must not have received prior chemotherapy or immunotherapy * Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration * Patients must have a Zubrod performance status of 0 - 2 * WBC >= 3,000/μl obtained within 14 days prior to registration * ANC >= 1,500/μl obtained within 14 days prior to registration * Platelet count >= 100,000/μl obtained within 14 days prior to registration * Serum bilirubin <= 1.5 x institutional upper limits of normal * Serum transaminase (SGOT or SGPT) must be <= 1.5 x the institutional upper limit of normal unless the liver is involved with the tumor, in which case serum transaminase (SGOT or SGPT) must be <= 5 x the institutional upper limit of normal; these tests must be obtained within 14 days prior to registration * Serum creatinine must be <= 2 X the institutional upper limit of normal * Patients with a known history of the following corneal diseases are not eligible: dry eye syndrome, Sjogren's syndrome, keratoconjunctivitis sicca, exposure keratopathy, Fuch's dystrophy or other active disorders of cornea * Patients known to be HIV-positive and receiving combination anti-retroviral therapy are not eligible due to possible pharmacokinetic interactions with OSI-774 * Patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease; patients must either be able to swallow and/or receive enteral medications via gastrostomy feeding tube; patients with intractable nausea or vomiting are not eligible * Pregnant or nursing women may not participate on this study because OSI-774 is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development; there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774; women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years * If day 14, 21, 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day; in calculating days of tests and measurements, the day a test or measurement is done is considered to be day 0; therefore, if a test is done on a Monday, the Monday two weeks later would be considered day 14; this allows for efficient patient scheduling without exceeding the guidelines * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

NCT_ID NCT00060307

Study_NameErlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer

Study Objectives Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma Conditions: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma Intervention / Treatment: DRUG: alvocidib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment * Durie-Salmon stage I or greater at diagnosis * Patients with non-secretory or oligo-secretory MM (defined as maximum urinary M-spike less than 200 mg/24 hours and a maximum serum M-spike less than 0.5 g/dL during entire disease course) must have at least 30% bone marrow plasma cells * Patients with secretory MM must have measurable disease defined as serum monoclonal protein of at least 1 g/dL or urinary M-spike of at least 200 mg/24 hours * Must have received at least 1, but no more than 5 prior therapy regimens * Patients who have had 4 or 5 regimens are allowed provided corticosteroids and/or thalidomide are part of the regimens * No more than 5 prior chemotherapy regimens (as long as 2 contained dexamethasone or thalidomide) * Prior autologous peripheral blood stem cell transplantation is considered 1 prior regimen * Performance status - ECOG 0 <= age <= 2 * Performance status - ECOG 0 <= age <= 3 if secondary to neuropathy or acute bone event (e.g., vertebral compression or rib fracture) * Absolute neutrophil count at least 750/mm^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * AST no greater than 2.5 times ULN * Creatinine no greater than 3 mg/dL * No myocardial infarction within the past 6 months * Peripheral neuropathy secondary to prior drug therapy or myeloma-associated neuropathy allowed * No other uncontrolled serious medical condition * No uncontrolled infection * No other active malignancy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * See Disease Characteristics * No prior allogeneic stem cell transplantation * At least 10 days since prior thalidomide * No concurrent biologic therapy * See Disease Characteristics * At least 2 weeks since prior myelosuppressive chemotherapy * No other concurrent chemotherapy * See Disease Characteristics * No concurrent corticosteroids (including as antiemetics) except chronic corticosteroids for disorders other than myeloma (e.g., rheumatoid arthritis or adrenal insufficiency) * Maximum dose allowed for prednisone is no more than 10 mg/day or hydrocortisone no more than 40 mg/day * At least 10 days since prior bortezomib or tipifarnib * Concurrent bisphosphonates allowed if on stable dose before study entry

NCT_ID NCT00047203

Study_NameFlavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma

Study Objectives The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in infant patients Conditions: Brain Cancer Intervention / Treatment: DRUG: Sugammadex Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients between the ages of 1 <= age <= 12 month, * ASA physical status 1 <= age <= 3 who underwent elective brain cancer surgery during general anesthesia were included in the study Exclusion Criteria: * younger than 1month or older than 12 months. * hepatic or renal failure * A history of allergy to study medication

NCT_ID NCT02708056

Study_NameSugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants

Study Objectives This 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm). Conditions: Gastric Cancer Intervention / Treatment: DRUG: Bevacizumab, DRUG: Placebo, DRUG: Capecitabine, DRUG: Cisplatin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced or metastatic disease, not amenable to curative therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 * Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) Exclusion Criteria: * Previous chemotherapy for locally advanced or metastatic gastric cancer * Previous platinum or anti-angiogenic therapy * Radiotherapy within 28 days of randomization * Evidence of Central Nervous System (CNS) metastasis at baseline

NCT_ID NCT00887822

Study_NameA Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer

Study Objectives In the proposed study, investigators will conduct a 90-day dietary intervention study in human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a comparable level of calcium alone. There will also be a placebo group. Prior to ingesting the study agents and following the course of treatment, colonic biopsies will be obtained by sigmoidoscopy and quantitatively examined for markers of growth and differentiation. In this study, metabolomic and microbial profiles will also be generated from fecal and colon mucosal samples taken at baseline and study endpoint. Conditions: Colonic Cancer Intervention / Treatment: DRUG: Aquamin®, DRUG: Calcium Carbonate, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Must be able to give written informed consent. * Be generally healthy, male or female, ages 18 <= age <= 80 old. * Must have one of the following: i)A first degree relative (father/mother, son/daughter, brother/sister) with colorectal cancer under the age of 60 at the time of diagnosis; OR ii)Participant have had a colorectal polyp. OR iii)Participant have previously had removed early stage colon cancer (stage I or II removed surgically and without recommendation for adjuvant therapy or with stage III colorectal cancer (CRC) treated with curative surgery >5 years ago). iv)Pre-menopausal women with intact female reproductive organs must have a negative pregnancy test within 2 weeks of the baseline flexible sigmoidoscopy. Post-menopausal is defined as no menses for the previous 12 months. If cessation of menses is within 12 months then the subject should be treated as pre-menopausal and a pregnancy test performed. Exclusion Criteria: * Must not be pregnant or lactating women and women of child bearing potential unwilling to use acceptable birth control throughout the study. * Participants must not have a history or diagnosis of any of the following conditions: i)Kidney disease, including kidney "stones" or hypercalcemia. ii)Crohn's disease, or inflammatory bowel disease. iii)Any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors) or active gastric / duodenal ulcers - peptic ulcer disease (without bleeding in last 3 months). iv)Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin. v)Hereditary and familial polyposis (HNPCC/ familial adenomatous polyposis (FAP); Lynch Syndrome) because these are rare conditions with unique etiology. * Participants will be excluded if they have taken the following, within the last 14 days or are unwilling to forgo the following for 14 days prior to entry into the study: i)Calcium, Vitamin D, ginger, or fish oil supplements, including multivitamins that have low amounts of calcium/Vitamin D and fiber supplements. ii)Non-steroidal anti-inflammatory medications (NSAIDS), such as Aspirin or Ibuprofen (except for occasional pain control or low dose aspirin for cardiovascular disease prevention). iii)Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps your body to regulate your stress response, immune response and inflammation). iv)Cephalosporin antibiotics (e.g., rocephin, keflex, omnicef).

NCT_ID NCT02647671

Study_NameAquamin and Prevention of Colon Cancer

Study Objectives This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients with small cell lung cancer that has returned after a period of improvement. Pegylated irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Recurrent Small Cell Lung Carcinoma Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: Pegylated Irinotecan, OTHER: Pharmacological Study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Written informed consent granted prior to initiation of any study-specific screening procedures, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice * Histologic or cytologic diagnosis of SCLC (Note: patients with mixed histology are not eligible) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Presence of measurable disease defined as >= 1 lesion whose longest diameter can be accurately measured as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) * Previously treated SCLC with only one prior treatment regimen (cyclophosphamide/doxorubicin/vincristine [CAV] alternating with etoposide/cisplatin [EP] is acceptable) * Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, hormonal therapy, or surgery to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1, except for diarrhea (which must be grade 0 without supportive antidiarrheal medications) and alopecia (any grade) * Platelet count >= 100 x 10^9/L * Hemoglobin (Hgb) >= 9 gm/dL * Absolute neutrophil count (ANC) >= 1500/uL * Serum creatinine =< 1.5 mg/dL or creatinine clearance > 45 mL/min; use either measured or calculated with Cockcroft-Gault formula * Serum total bilirubin =< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN or =< 5 x ULN if caused by liver metastasis * Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug; male and female subjects of child-bearing potential must agree to use double-barrier contraceptive measures, or avoidance of intercourse during the study and for 6 months after last investigational drug dose received Exclusion Criteria: * Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first day of study defined treatment; palliative radiation < 2 weeks, biological therapy within 2 weeks, hormonal therapy within 1 week prior to day 1 cycle 1 * Prior treatment with a topoisomerase-I inhibitor (e.g., topotecan, irinotecan) * Prior malignancy except for non-melanoma skin cancer and carcinoma in situ, unless diagnosed and definitively treated more than 5 years prior to enrollment * Substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results * Known human immunodeficiency virus (HIV) infection * Pregnancy or breast-feeding * Concurrent administration or received cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors within 2 weeks prior to the first day of study drug treatment * Patients with chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to study entry * Major surgery < 4 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy, etc) < 2 weeks prior to the first day of study defined treatment * Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy); brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Unwilling or unable to follow protocol requirements

NCT_ID NCT01876446

Study_NamePegylated Irinotecan NKTR 102 in Treating Patients With Relapsed Small Cell Lung Cancer

Study Objectives This is an open-label, phase 1 study of ascending multiple oral doses of HKI-272 in combination with paclitaxel. Conditions: Advanced Malignant Solid Tumors Intervention / Treatment: DRUG: Neratinib, DRUG: Paclitaxel Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects must have confirmed pathologic diagnosis of a solid tumor that is not curable with available therapy for which HKI-272 plus paclitaxel is a reasonable treatment option. * At least 1 measurable lesion as defined by RECIST criteria. * Eastern Cooperative Oncology Group (ECOG) 0 to 1 * LVEF within institutional limits of normal (by MUGA or ECHO). * Screening laboratory values within the following parameters: * ANC: greater than or equal to 1.5 x 10E9 /L (1,500 /mm3) * Platelet count: 10 x 10E10 /L (100,000 /mm3) * Hemoglobin: greater than or equal to 9.0 g/dL * Serum creatinine: less than or equal to 1.5 x upper limit of normal (ULN) * Total bilirubin: less than or equal to 1.5 xULN · AST and ALT: less than or equal to 2.5 xULN (less than or equal to 5 x ULN if liver metastases are present) * For women of child bearing potential, a negative urine or serum pregnancy test result before study entry. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or other means of birth control or whose sexual partners are either sterile or using contraceptives. * All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 28 days after the last dose of test article. Exclusion Criteria: * Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m^2, epirubicin dose of greater than 800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives. * Major surgery, chemotherapy, radical (curative intent) radiotherapy, investigational agents, or other cancer therapy within 2 weeks of treatment day 1 or non-recovery from all clinically significant acute adverse effects of prior therapies (excluding alopecia). * Subjects with bone or skin as the only site of disease. * Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (subjects with a history of CNS metastases or cord compression are allowable if they have been definitively treated and have been clinically stable for at least three months, and off steroids or anticonvulsants, before first dose of test article). * QTc interval greater than 0.47 second or known history of QTc prolongation or Torsade de Pointes (TdP). * Known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil). * Pregnant or breast feeding women. * Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade greater than or equal to 2 diarrhea of any etiology at baseline). * Inability or unwillingness to swallow the HKI-272. * Treatment with a taxane within 3 months of treatment day 1. * Pre-existing grade 2 or greater motor or sensory neuropathy. * Any other cancer within 5 years prior to screening with the exception of contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin. * Presence of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association [NYHA] functional classification of greater than or equal to 2), angina requiring treatment, myocardial infarction within the past 12 months, or any clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention. * Evidence of significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, make the subject inappropriate for this study. Examples include, but are not limited to, serious active infection (ie, requiring intravenous antibiotic or antiviral agent), uncontrolled major seizure disorder, or significant pulmonary disorder (e.g. interstitial pneumonitis, pulmonary hypertension).

NCT_ID NCT00768469

Study_NameStudy Evaluating Safety And Tolerability, Solid Tumor

Study Objectives The Influence of ARTISS on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients. Conditions: Breast Neoplasms, Mammaplasty Intervention / Treatment: DRUG: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen), OTHER: no ARTISS Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Female adult (age 18 <= age <= 80) * Patients planned for immediate or delayed DIEP/MS-TRAM breast reconstruction Exclusion Criteria: * Patients who are unable to consent or do not consent * Clotting disorder * Pregnancy * Individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia). * COVID positive * Known previous allergic reactions to ARTISS

NCT_ID NCT04931615

Study_NameARTISS a Single-centre Randomised Control Study

Study Objectives The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine in patients with pancreatic cancer. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Gemcitabine, DRUG: LY293111, DRUG: placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Adenocarcinoma of the pancreas that is locally advanced or metastatic and not amenable to resection with curative intent * Tumor that can be measured by x-ray or scan * Adequate organ function Exclusion Criteria: * Inability to swallow capsules * Documented brain metastases * Prior chemotherapy or biological therapy for this disease

NCT_ID NCT00055250

Study_NameA Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer

Study Objectives For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons. The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl. Conditions: Advanced Solid Cancers Intervention / Treatment: DRUG: oxycodone fentanyl Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking * Histologically Confirmed Solid Cancer * Aged Over 18 Years * Admitted in a Palliative Cancer Care Unit Exclusion Criteria: * Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease * Inability to swallow oral medication, and impaired sensory or cognitive function * Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind

NCT_ID NCT00478101

Study_NameOpioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

Study Objectives This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy. Conditions: Breast Cancer Intervention / Treatment: DRUG: Trastuzumab, DRUG: Doxorubicin, DRUG: Cyclophosphamide, DRUG: Paclitaxel, DRUG: Docetaxel, DRUG: Carboplatin, DRUG: Neo-adjuvant chemotherapy Location: Algeria, Morocco, Tunisia, Turkey, Saudi Arabia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1 * Hormonal therapy will be allowed as per institutional guidelines * Prior use of anti-HER2 therapy will be allowed, except for early breast cancer participants in the neo-adjuvant setting * Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrollment * HER2-positive disease immunohistochemistry 3 plus (IHC3+) or in situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay * Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast * No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) * Use of concurrent curative radiotherapy will be permitted Exclusion Criteria: * History of other malignancy which could affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and participants with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible * Severe dyspnea at rest or requirement for supplementary oxygen therapy * Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness * Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension * Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) * Pregnant or lactating women * Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment * Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma * Inadequate bone marrow, hepatic or renal function

NCT_ID NCT01964391

Study_NameA Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer

Study Objectives This non-interventional retrospective study will describe real-world treatment patterns and clinical outcomes among adults with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib as a first or later line of therapy. Patients will be identified from the Flatiron Electronic Health Record database. Conditions: Metastatic Breast Cancer, Breast Neoplasms Intervention / Treatment: DRUG: Talazoparib Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * Diagnosed with breast cancer (ICD-9 174.x or 175.x or ICD-10 C50x) * At least two visits in the Flatiron database on or after January 1, 2011 * Pathology consistent with breast cancer * Has evidence of stage IV or recurrent metastatic breast cancer with a metastatic diagnosis date on or after January 1, 2011. This includes patients who were diagnosed with stage IV at diagnosis or were diagnosed with earlier stage disease, then developed a distant metastasis later on, or had recurrence of the disease via a distant metastasis * Confirmed receipt of talazoparib as treatment for mBC via abstraction initiated between January 1, 2018 and September 30, 2020 * HER2 negative test result on or before the start of patient's first talazoparib-containing line of therapy, as defined by Flatiron's line of therapy rules * BRCA1, BRCA2, BRCA1 and BRCA2 germline mutation, or BRCA germline mutation not otherwise specified, identified on or before the start date of patient's first talazoparib-containing line of therapy, as defined by Flatiron's line of therapy business rules * Age >= 18 years at the time of first talazoparib-containing line of therapy Exclusion Criteria: * Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team * Receipt of drug as part of a clinical trial (captured in the database as "clinical study drug" without additional information about active ingredient or whether the patient received placebo), defined as any non-cancelled order, administration, or oral episode for a drug used in a clinical trial, on or prior to start of first talazoparib line of therapy, as defined by Flatiron's line of therapy business rules

NCT_ID NCT05141708

Study_NameTreatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m

Study Objectives The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS). Conditions: Cervical Cancer Intervention / Treatment: BIOLOGICAL: Pembrolizumab, DRUG: Paclitaxel, DRUG: Cisplatin, DRUG: Carboplatin, BIOLOGICAL: Bevacizumab, DRUG: Placebo to pembrolizumab Location: Peru, Australia, France, Korea, Republic of, Chile, Canada, Turkey, Ukraine, Germany, Spain, Italy, Taiwan, Argentina, Israel, United States, Japan, Russian Federation, Colombia, Mexico Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). Prior chemotherapy utilized as a radiosensitizing agent and completed at least 2 weeks prior to randomization with resolution of all treatment-related toxicities is allowed. AEs due to previous treatments should be resolved to <= Grade 1 or baseline. Participants with <= Grade 2 neuropathy or <= Grade 2 alopecia are eligible. * Not pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab * Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology * Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization * Has adequate organ function Exclusion Criteria: * A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable. * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have undergone potentially curative therapy are not excluded. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization * Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of Hepatitis B or known active Hepatitis C virus infection * Has a known history of active tuberculosis (TB; Bacillus tuberculosis) * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137) * Has received prior systemic chemotherapy for treatment of cervical cancer. * Has not recovered adequately from toxicity and/or complications from major surgery prior to randomization * Has received prior radiotherapy within 2 weeks prior to randomization. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. * Has received a live vaccine within 30 days prior to randomization * Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients. * Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization * Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days following last dose of pembrolizumab/placebo and 210 days following last dose of chemotherapy/bevacizumab * Has had an allogeneic tissue/solid organ transplant

NCT_ID NCT03635567

Study_NameEfficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

Study Objectives This phase II trial studies the side effects and how well white blood cells taken from person's own (autologous) cluster of differentiation (CD)8+ antigen-specific T cells, cyclophosphamide, aldesleukin, and ipilimumab work in treating patients with melanoma that has spread to another place in the body. Autologous CD8+ antigen-specific T cells are white blood cells that are designed in the laboratory to find melanoma cells and may kill them. Biological therapies, such as aldesleukin, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving autologous CD8+ antigen-specific T cells with cyclophosphamide, aldesleukin, and ipilimumab may be an effective treatment for patients with metastatic melanoma. Conditions: Metastatic Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7 Intervention / Treatment: BIOLOGICAL: Aldesleukin, BIOLOGICAL: Autologous CD8+ Melanoma Specific T Cells, DRUG: Cyclophosphamide, BIOLOGICAL: Ipilimumab, OTHER: Laboratory Biomarker Analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * ELIGIBILITY FOR ENROLLMENT * Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease * Expression of human leukocyte antigen (HLA)-A2 * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of '0 <= age <= 1' at screening visit * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized; suggested precautions should be used to minimize the risk of pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion, and at least 8 weeks after the study drug is stopped; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal * Men must be willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if their sexual partners are WOCBP * Willing and able to give informed consent * Adequate venous access - consider peripherally inserted central catheter (PICC) or central line * Evaluation of v-raf murine sarcoma viral oncogene homolog B (BRAF)V600 mutation status * Measurable tumor (by Response Evaluation Criteria in Solid Tumors [RECIST] criteria) * Melan-A (MART) 1 or solute carrier family 45, member 2 (SLC45A2) (+) staining results; (if patients have not had staining test in the past, the test will be run after patient consent is obtained, but before enrollment) * ELIGIBILITY FOR TREATMENT (INCLUDES CYCLOPHOSPHAMIDE, T CELL, ANTI-CTLA4 INFUSIONS AND SC IL-2) * ECOG/Zubrod performance status of '0 <= age <= 1' * At least 4 weeks must have elapsed since the last chemotherapy, radiotherapy or major surgery; at least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin; if started before T-cell administration, ipilimumab infusions must be least 21 days apart * Toxicity related to prior therapy must either have returned to =< grade 1, baseline, or been deemed irreversible * Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 8 weeks after study drug is stopped * Willing and able to give informed consent. Exclusion Criteria: * EXCLUSION FOR ENROLLMENT * Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix * Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception; women of childbearing potential with a positive pregnancy test within 3 days prior to entry * Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening magnetic resonance imaging [MRI] or contrast computed tomography [CT]) * No signs or symptoms of CNS metastases (mets) within the last 30 days (from enrollment evaluation) * No single lesion larger than 1 cm * No more than 5 lesions * Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable * Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea * Positive screening tests for human immunodeficiency virus (HIV), hepatitis B (hep B), and hepatitis C (hep C) (referencing blood draw at leukapheresis screening); if positive results are not indicative of true active or chronic infection, the patient can be treated * White blood cells (WBC) =< 1000/uL * Hematocrit (Hct) =< 24% or hemoglobin (Hb) =< 8 g/dL * Absolute neutrophil count (ANC) =< 500 * Platelets =< 50,000 * Creatinine >= 3.0 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >= 2.5 x ULN * Bilirubin >= 3 x ULN * Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy * Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose * Patients may not be on any other treatments for their cancer aside from those included in the protocol; patients may not undergo another form of treatment concurrently with this study * EXCLUSION CRITERIA FOR TREATMENT * WBC =< 1000/uL (prior to cyclophosphamide and T cell infusions) * Hct =< 24% or hemoglobin =< 8 g/dL (prior to cyclophosphamide and T cell infusions) * ANC =< 500 (prior to cyclophosphamide and T cell infusions) * Platelets =< 50,000 (prior to cyclophosphamide and T cell infusions) * Creatinine >= 3.0 x ULN (prior to cyclophosphamide and T cell infusions) * AST/ALT >= 2.5 x ULN (prior to cyclophosphamide and T cell infusions) * Bilirubin >= 3 x ULN (prior to cyclophosphamide and T cell infusions) * Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception; women of childbearing potential with a positive pregnancy test within 3 days prior to entry. * Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy. * Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose. * Patients may not be on any other treatments for their cancer aside from those included in the protocol. Patients may not undergo another form of treatment concurrently with this study. * Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening MRI or contrast CT): * No signs or symptoms of CNS mets within the last 30 days (from enrollment evaluation). * No single lesion larger than 1cm * No more than 5 lesions

NCT_ID NCT02027935

Study_NameCD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma

Study Objectives The primary objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of unesbulin in combination with dacarbazine for the treatment of advanced LMS and determine the overall safety profile of unesbulin in combination with dacarbazine. This study will employ the time-to-event continual reassessment method (TITE-CRM) for dose finding. Treatment will be initiated at dose level 2 (DL2) (Dacarbazine 1000 milligrams per square meter \[mg/m\^2\] intravenously \[IV\] every 21 days in combination with unesbulin 200 milligrams \[mg\] orally twice weekly) for the first participant. This dose level represents the investigator's best assessment of the MTD based on available toxicity data for both agents. For subsequent participants, the dose level at which treatment is initiated will be selected based on the TITE-CRM using the most up to date dose-limiting toxicity (DLT) information from all participants previously treated. To enroll additional participants at the RP2D, the study is amended to include an expansion cohort of up to 12 participants (some of whom could be ongoing participants who reconsent). Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason. Conditions: Leiomyosarcoma Intervention / Treatment: DRUG: Unesbulin, DRUG: Dacarbazine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed consent of an Institutional Review Board (IRB)-approved informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information (if appropriate). * Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. * Disease Status including all of the following: 1. Histological or cytological confirmation of LMS arising at any anatomic site. 2. Advanced (metastatic) or locally advanced unresectable disease. 3. Ineligible for other high-priority national or institutional study. 4. Measurable disease per RECIST v1.1 criteria. Demographics: * Age greater than or equal to (>=) 18 * Male and Female Performance Status: * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1. Hematopoietic: * Absolute neutrophil count (ANC) count >= 1,500/cubic millimeters (mm^3) without the use of growth factors in the past 7 days; * Platelet count >=100,000/mm^3 without platelet transfusion in the past 5 days; * Hemoglobin >=9 grams per deciliter (g/dL) (packed red blood cell transfusion is allowed). Hepatic: * Bilirubin lesser than (<) upper limit of normal (ULN); * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <1.5 times ULN; * Participants with liver metastases may be enrolled. Pulmonary: * Participants with well-controlled asthma (for example Use of rescue medications <2 times/week over the last 12 months) or Chronis Obstructive Pulmonary Disease (COPD) (for example no exacerbations over the prior 3 months) may be enrolled. Renal: * Creatinine <1.5 times normal, or creatinine clearance greater than (>) 45 milliliters per minute (mL/min). Prior Therapies: * Toxicity from prior therapies recovered to Grade lesser than or equal to (<=) 1 or participant's baseline, except for alopecia. In addition, endocrinopathies associated with prior immunotherapy based treatments which are well controlled on replacement medication are not exclusionary * Chemotherapy: a. Up to and inclusive of 4 prior systemic cytotoxic oncology therapy regimens for metastatic, locally recurrent, or unresectable LMS, with the last dose of prior therapy administered no fewer than 30 days or 5 times the drug half-life prior to screening. Note: prior treatment with non-cytotoxic therapy regimens (for example targeted therapies, hormonal therapies, or tyrosine kinase inhibitors) are not considered cytotoxic oncology therapies. Surgery: * At least 4 weeks since prior surgery and recovered in opinion of investigator. Other: * Capable of swallowing oral medication. * Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. * Males and females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 90 days after treatment discontinuation. Note: The Definition of effective contraception will be based on the judgement of the Principal Investigator (PI) or Designee. Exclusion Criteria: Participants meeting any of the following criteria will not be eligible for enrollment: * Received any systemic anticancer therapy including investigational agents <=3 weeks prior to initiation of study treatment. Additionally, Participants may have not received radiation <= 3 weeks prior to initiation of study treatment. * Co-existing active infection or any co-existing medical condition likely to interfere with study procedures, including: a. Significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease), myocardial infarction within the past 6 months, unstable angina, congestive heart failure requiring therapy, unstable arrhythmia or a need for anti-arrhythmic therapy, or evidence of ischemia on electrocardiogram (ECG), marked baseline prolongation of QT/QTc (corrected QT interval) interval, for example, repeated demonstration of a QTc interval >500 milliseconds (msec) (Long QT Syndrome [congenital]). * Known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) positivity. * History of solid organ transplantation. Therapeutics: * Known or suspected allergy or immediate or delayed hypersensitivity to unesbulin or dacarbazine or any agent given in this study. Gastrointestinal: * Bowel obstruction, malabsorption, or other contraindication to oral medication. * Gastrointestinal disease or other condition that could affect absorption. * Active peptic ulcer disease. * Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis. * Any condition that impairs participant's ability to swallow oral medications. Wounds /Surgery: * Serious non-healing wound, ulcer, or bone fractures. * Major surgery, open biopsy or significant traumatic injury which has not recovered in the opinion of the investigator, within 28 days of baseline. * Mucosal or internal bleeding. Concomitant Medications: * Concomitant strong CYP1A2 inhibitors (like selective serotonin reuptake inhibitor [SSRI] agents fluvoxamine and fluoxetine) should be avoided. CYP1A2 inhibitors may inhibit the conversion of dacarbazine to its active metabolite and may increase the exposure of unesbulin. Other: * Prior malignancies other than LMS, that required treatment or have shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to initiation. Cancer treated with curative intent more than 5 years previously and without evidence of recurrence is not an exclusion. * Known coagulopathy or bleeding diathesis. Participants on anti-coagulation should be monitored closely and International Normalized Ratio (INR) within normal range. * Prior or ongoing clinically significant illness, medical or psychiatric condition, medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, or alter the absorption, distribution, metabolism, or excretion of the study drugs, or could impair the assessment of study results. * History of brain metastases or leptomeningeal disease at any time in participant's history, including treated central nervous system (CNS) disease which is clinically and radiographically stable.

NCT_ID NCT03761095

Study_NameA Study of Unesbulin (PTC596) in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)

Study Objectives We plan to conduct a phase I/II clinical trial using biweekly gemcitabine, oxaliplatin, and 48-hour infusion of high dose 5-FU/leucovorin to treat patients with advanced pancreatic adenocarcinoma. In the phase I part, the maximum tolerable dose of oxaliplatin in combination with biweekly gemcitabine 800 mg/m2 and 48-hour infusion of 5-FU 3000 mg/m2 and leucovorin 300 mg/m2 will be determined. In the phase II part, the efficacy and safety of the biweekly chemotherapy with GOFL will be evaluated. Conditions: Pancreatic Adenocarcinoma Intervention / Treatment: DRUG: oxaliplatin, DRUG: gemcitabine, DRUG: 5-FU/LV Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 5.1.1 Patients must have metastatic or unresectable adenocarcinoma of the pancreas. The diagnosis of pancreatic adenocarcinoma must be confirmed by histopathology or cytology. *1.2 For the phase I part of this trial, patients who have disease measurable or evaluable on x-ray, CAT scan, or physical examination are eligible. For the phase II part of this trial, only patients who have disease measurable on x-ray, CAT scan, or physical examination are eligible. *1.3 Patients must have no history of prior chemotherapy. 5.1.4 Patients with prior radiotherapy are eligible if the irradiated area is not the only source of measurable or evaluable disease. *1.5 Patients' baseline ECOG performance status must be £ 2. 5.1.6 Patients' life expectancy must be 12 weeks or greater. 5.1.7 Patients' age must be ³ 20 and £ 75. 5.1.8 Patients must have adequate bone marrow function, defined as WBC count ³ 3,500/ul, neutrophil count ³ 1,500/ul, and platelet count ³ 100,000/ul. *1.9 Patients must have adequate liver function and adequate renal function, defined as the following: serum alanine (ALT) £ 5 times upper normal limit, serum total bilirubin level £ 2.0 mg/dL, and serum creatinine £ 1.5 mg/dL. *1.10 Patients who have biliary obstruction and have undergone adequate drainage procedures before enrollment are eligible. *1.11 Patients must agree to have indwelling venous catheter implanted. 5.1.12 Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. *1.13 All patients must be informed of the investigational nature of this study and must sign and give written informed consent. Exclusion Criteria:5.2.1 Patients who have central nervous system metastasis 5.2.2 Patients who have active infection 5.2.3 Pregnant or breast-nursing women 5.2.4 Patients who have active cardiac disease or history of ischemic heart disease 5.2.5 Patients who have peripheral neuropathy > Grade I of any etiology 5.2.6 Patients who have serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) 5.2.7 Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin 5.2.8 Patients who are under biologic treatment for their malignancy *

NCT_ID NCT00154791

Study_NamePhase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma

Study Objectives This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic esophageal squamous cell carcinoma patients. Conditions: Esophageal Squamous Cell Carcinoma Intervention / Treatment: RADIATION: SMART, DRUG: DDP, DRUG: S-1 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologically or cytologically confirmed esophageal squamous cell carcinoma. * Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies. * Aging from 70 to 80. * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2. * Charlson's weighted index of comorbidities (WIC) <=4； * White blood cell count >=4×109 /L, neutrophile granulocyte count>=1.5×109 /L, platelet count>=100×109 /L, hemoglobin >=100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN. * Weight loss <=15% within the past half year. * Forced expiratory volume in 1 s>= 1 L. * Patients and their family signed the informed consents. Exclusion Criteria: * Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ. * Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation. * Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.) * Malignant pleural effusion or pericardial effusion. * Weight loss >10% within the past 3 months. * Recruited in other clinical trials within 30 days * Drug addiction, long-term alcohol abuse and AIDS patients. * Uncontrollable epileptic attack or psychotic patients without self-control ability. * Severe allergy or idiosyncrasy. * Not suitable for this study judged by researchers.

NCT_ID NCT02606916

Study_NameRadiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.

Study Objectives Primary Objective: 1. To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+) CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation. Secondary Objectives: 1. To identify any clinically significant drug interactions with imatinib in the post-transplant setting. 2. To develop specific monitoring parameters for imatinib use when utilized in the early post-BMT setting. 3. To record one-year survival data in this patient cohort to assess any effect of early imatinib administration on this endpoint. Conditions: Leukemia Intervention / Treatment: DRUG: Imatinib Mesylate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with Ph(+) CML and/or CML with bcr-abl rearrangement and diploid cytogenetics not eligible for protocols of higher priority (e.g. ID02 <= age <= 901, DM99 <= age <= 081, DM97 <= age <= 206, etc). * The disease must be beyond first chronic phase according to IBMTR criteria (i.e. accelerated phase, blastic phase, second chronic phase) at the time of transplant. * Patients with Ph(+) acute lymphocytic (or myeloid) leukemia. * Patients with diploid cytogenetics but molecular evidence of bcr-abl rearrangement are also eligible. * Age >= 16 years * Unsupported ANC at least 1500 and unsupported platelet count of at least 50K following BMT. * Patients may have received prior chemotherapy for their disease or be previously untreated. * Patients must have received an allogeneic bone marrow or stem cell transplant. Allogeneic transplant types may include matched sibling donors, mismatched related donors, or unrelated donors. All preparative regimens acceptable. * Signed informed consent * Zubrod status <= 3 * Adequate hepatic (bilirubin <= 3 mg/dl, transaminases < 4 x upper limit of normal) and renal function (serum creatinine <= 3 mg/dl ) Exclusion Criteria: * Grade III/IV cardiac problems as defined by the NYHAC * History of hypersensitivity to imatinib * Pregnant and lactating women * HIV positive

NCT_ID NCT00386373

Study_NameUse and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients

Study Objectives The purpose is to identify a dose of SB-485232 which is safe, tolerable and effective when used in combination with Rituximab in patients with non-Hodgkin's lymphoma (NHL). This study will use a standard treatment regimen of Rituximab in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies. Conditions: Lymphoma, Non-Hodgkin Intervention / Treatment: DRUG: SB-485232, DRUG: Rituximab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed diagnosis of any subtype of CD20+ B cell NHL. Subjects must have disease that progressed after standard therapy or for which there is no effective standard therapy (including high-dose therapy and autologous stem cell transplantation). NOTE: If the subject has had a prior autologous stem cell transplant, it must have occurred at least three months prior to screening and the subject must be fully recovered from any acute toxicities. * Prior treatment with Rituximab is allowed, provided it was completed at least six months before study enrollment. * Male or female >= 18 years. * Measurable or evaluable disease. * Predicted life expectancy of at least 12 weeks. * ECOG Performance Status of 0 or 1. * No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within four weeks before beginning treatment with SB-485232 (6 weeks for nitrosoureas and mitomycin C). Subjects must have recovered from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study. * A signed and dated written informed consent form is obtained from the subject. * The subject is able to understand and comply with protocol requirements, timetables, instructions and protocol-stated restrictions. The subject is likely to maintain good venous blood access for PK and PD sampling throughout the study. * A female is eligible to enter and participate in the study if she is of: a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who: * has had a hysterectomy, * has had a bilateral oophorectomy (ovariectomy), * has had a bilateral tubal ligation, * is post-menopausal (demonstrate total cessation of menses for greater than 1year), If amenorrheic for less than one year, post-menopausal status will be confirmed by serum follicle stimulating hormone (FSH) and oestradiol concentrations at screening. or, b. childbearing potential, has a negative serum pregnancy test at the Screen Visit, and agrees to one of the following GSK acceptable contraceptive methods: * any intrauterine device (IUD) with a documented failure rate of less than 1% per year. * vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female. * oral contraceptive (either combined or progesterone only). * because of the unacceptable failure rate of barrier (chemical and/or physical) methods, the barrier method of contraception must only be used in combination with other acceptable methods described above. * Adequate organ function, Exclusion Criteria: * Women who are pregnant or are breast-feeding. * Significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or autoimmune conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial. * The subject has diabetes mellitus with poor glycemic control. * The subject has a history of human immunodeficiency virus (HIV) or other immunodeficiency disease. * The subject has positive Hepatitis B surface antigen. * Corrected QT interval (QTc) > 480msec. * The subject has a history of a severe infusion related reaction or tumor lysis syndrome following treatment with Rituximab (Section 10.2.2). * The subject has a circulating malignant cell count > 25,000/mm3 in peripheral blood. * The subject has known anaphylaxis or IgE-mediated hypersensitivity to murine proteins. * The subject has an acute infection or severe or uncontrolled infections requiring systemic antibiotic therapy. * Any serious medical or psychiatric disorder that would interfere with subject safety or informed consent. * Known leptomeningeal disease or evidence of prior or current metastatic brain disease. Routine screening with central nervous system (CNS) imaging studies (CT or MRI) is required only if clinically indicated. * Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy. * Oral corticosteroids within 14 days of study entry. * History of alcohol abuse within six months of screening or alcohol consumption in the past six months exceeding seven drinks/week for women and 14 drinks/week for men (where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor). * History of ventricular arrhythmias requiring drug or device therapy. * Any unresolved or unstable serious toxicity from prior administration of another investigational drug. * Any investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of SB-485232. * Donation of blood in excess of 500 mL within a 56-day period prior to dosing.

NCT_ID NCT00500058

Study_NameA Phase I, Dose-Escalation Study to Assess the Safety and Biological Activity of Recombinant Human Interleukin-18

Study Objectives This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available. Conditions: Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma Intervention / Treatment: DRUG: Alisertib, DRUG: Pralatrexate, DRUG: Gemcitabine, DRUG: Romidepsin Location: Peru, Poland, United Kingdom, Australia, Austria, Puerto Rico, Denmark, Egypt, France, Chile, Netherlands, Belarus, Canada, Turkey, Slovakia, New Zealand, Portugal, Germany, Sweden, Spain, Czechia, Italy, Romania, Israel, United States, Brazil, Bulgaria, Belgium, Russian Federation, Mexico, Hungary Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Male or female participants age >= 18 years * Participants with Peripheral T cell lymphoma (PTCL) (selected subtypes) according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytotoxic therapy for PTCL. Participants must have received conventional therapy as a prior therapy. Cutaneous-only disease is not permitted. Participants must have documented evidence of progressive and measurable disease. * Tumor biopsy available for central hematopathologic review * Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 2 * Female participants who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse. * Male participants who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse * Suitable venous access * Voluntary written consent Exclusion Criteria * Known central nervous system lymphoma * Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study * Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known hypersensitivity) * History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness * Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40% * Concomitant use of other medicines as specified in study protocol * Participants with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors * Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C * Autologous stem cell transplant less than 3 months prior to enrollment * Participants who have undergone allogeneic stem cell or organ transplantation any time * Inadequate blood levels, bone marrow or other organ function as specified in study protocol * The participant must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade <= 1 toxicity, to participant's baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy * Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment * Female participants who are breastfeeding or pregnant * Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years * Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol

NCT_ID NCT01482962

Study_NameAlisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Study Objectives Regorafenib is a novel oral multi-kinase inhibitor which targets angiogenic, stromal and oncogenic receptor tyrosine kinases. It is currently registered for GIST and mCRC. When regorafenib is co-administered with an acid suppressive agent, the intra-gastric pH increases, and as a result the equilibrium of ionized/non-ionized regorafenib may shift to the less soluble non-ionized form which reduces regorafenib bioavailability and exposure. Since proton pump inhibitors (PPIs) are often used during regorafenib therapy, this drug-drug interaction (DDI) confronts pharmacists and oncologists with challenges in clinical practice. In this study the investigators will therefore evaluate the impact of PPI-induced intra-gastric pH elevation on regorafenib pharmacokinetics in patients with GIST and mCRC. Conditions: Colorectal Neoplasms, Gastrointestinal Stromal Tumors Intervention / Treatment: DRUG: Esomeprazole 40mg concomitantly, DRUG: Esomeprazole 40mg before, DRUG: Regorafenib 160mg or 120mg Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Age >= 18 years * Histological or cytological confirmed diagnosis of mCRC or GIST and prior treatment specific: 1. mCRC-patients who have been previously treated with, or are not considered candidates for, available therapies according to common practice. 2. Irresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib. * ECOG Performance Status <= 1 * Able and willing to sign the Informed Consent Form * No concurrent (over the counter) use of other acid reducing drugs (PPIs, H2As and/or antacids), other than esomeprazole 40mg once daily during the study. * No concurrent medication or supplements which can interact with esomeprazole or regorafenib during the study period. * Abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study period. * Adequate baseline patient characteristics (complete blood count, and serum biochemistry which involves sodium, potassium, creatinin, calculation of creatinin clearance (MDRD), AST, ALT, gamma glutamyl transpeptidase, lipase, lactate dehydrogenase, ALP, total bilirubin, albumin, glucose, INR, thyroid function tests, and PTT or APTT within two weeks prior to the study). Exclusion Criteria: * Pregnant or lactating patients. * Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria). * Known serious illness or medical unstable conditions that could interfere with this study; requiring treatment (e.g. infection, bleedings, uncontrolled hypertension despite optimal medical management, HIV, hepatitis, organ transplants, kidney, cardiac and respiratory diseases). * Non-healing wound, non-healing ulcer, or non-healing bone fracture * Major surgical procedure or significant traumatic injury within 28 days before start of study medication. * Patients with evidence or history of any bleeding diathesis, irrespective of severity * Any hemorrhage or bleeding event >= CTCAE Grade 3 within 4 weeks prior to the start of study medication. * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 month before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication) * Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) * Myocardial infarction less than 6 months before start of study drug. * Uncontrolled cardiac arrhythmias * Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent. * Interstitial lung disease with ongoing signs and symptoms at the time of informed consent * Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. * Known history of HIV infection, active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy. * Patients on strong CYP3A4 inhibitors or inducers are not eligible for the study (see appendix B). * The use of BCRP or P-glycoprotein substrates which leads to a clinically relevant drug-drug interaction concerning the pharmacokinetics of regorafenib. * Unwillingness to abstain from grapefruit (juice), (herbal) dietary supplements, herbals, over-the-counter medication (except for paracetamol and ibuprofen) and other drugs known to seriously interact with esomeprazole and regorafenib during the study period. * Unwillingness to abstain from acid beverages such as orange juice and other acidic beverages (e.g. Coca-Cola, 7-UP etc.) in the morning (between 06.00 <= age <= 14.00u AM) during regorafenib treatment in this study.

NCT_ID NCT02800330

Study_NameThe Effects of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib

Study Objectives The purpose of this study is to assess the feasibility of conducting a larger randomized controlled trial to assess the efficacy of perioperative propranolol capsules compared with placebo capsules in decreasing recurrence of prostate cancer (PCa) after robotic assisted laparoscopic prostatectomy (RALP) in participants with intermediate to high-risk for prostate cancer recurrence. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Propranolol Location: Norway Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * European Association of Urology Intermediate- and High Risk for Biochemical recurrence and planned for curative RALP * ECOG Performance Status 0 <= age <= 1 Exclusion Criteria: Medical Conditions * Sick sinus syndrome * Atrioventricular (AV) block grade 2 and 3 * Recent (3 months) myocardial infarction * Known unstable- or vasospastic- angina * Heart failure (New York Heart Association [NYHA] > 2) * Symptomatic peripheral vascular disease (e.g. intermittent claudication) * Known pulmonary hypertension * Known carotid artery stenosis or recent (3 months) stroke * Bronchial asthma or other chronic obstructive pulmonary disease (COPD) * Kidney failure (estimated Glomerular filtration rate [eGFR]<50) * Liver failure (cirrhosis, jaundice, signs of hepatic decompression) * Unregulated diabetes mellitus * Untreated thyroid disorder * Depressive episode within last 6 months (within last 12 months if major depressive episode) * Known drug allergy against propranolol or excipients * Any medical conditions considered to prohibit Propranolol use as judged by the treating physician (including frailty). * Participants with known substance- or alcohol-abuse Prior/Concomitant Therapy * Recent (<3 month) use of systemic beta-blockers prior to screening. * Patients receiving non-dihydropyridine calcium channel blocking agents (eg diltiazem, verapamil) * Patients receiving anti-arrhythmic agents (e.g. amiodarone, sotalol, digoxin, verapamil, flecainide) * Patients receiving digoxin, rizatriptan, hydralazine, fluvoksamin, or fluoksetin * Patients using daily anxiolytics (e.g. benzodiazepines), alpha-receptor adrenergic agonists (e.g. clonidine) * Recommendations in the Summary of Product Characteristics for propranolol regarding concomitant use of other medications will be adhered to. Diagnostic assessments * Sinus bradycardia (<60 beats/minute) * Resting blood pressure <110/60mmHg OR hypertension BP >160/100 * AV-block 2 or 3 on ECG

NCT_ID NCT05679193

Study_NamePerioperative Propranolol During Prostatectomy to Decrease Cancer Recurrence

Study Objectives Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of patients with polycystic ovary syndrome (PCOS). To date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data are available on the CVR in PCOS patients treated with OC or physical exercise. The purpose of this study is to compare the effects of OC to physical exercise on the CVR of PCOS women and show the hormonal and metabolic effects of these two different treatment. We hypothesize that physical exercise has the same beneficial effects of OC therapy on hormonal and metabolic features of PCOS women with less cardiovascular consequences. Conditions: Polycystic Ovary Syndrome Intervention / Treatment: BEHAVIORAL: Physical exercise, DRUG: OC - Drospirenone plus Ethynylestradiol, DIETARY_SUPPLEMENT: Vitamin, polyvitamins tablets Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Polycystic ovary syndrome Exclusion Criteria: * Age <18 or >40 years * BMI higher than 30 and lower than 18 * Pregnancy * Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of OC, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months * Subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea)

NCT_ID NCT00593294

Study_NameOral Contraceptive and Cardiovascular Risk in PCOS

Study Objectives This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission. Assessing why young patients who have acute lymphoblastic leukemia may not take their medications as prescribed may help identify ways to assist them in taking their medications more consistently and may improve long-term treatment outcomes. Conditions: Childhood Acute Lymphoblastic Leukemia in Remission Intervention / Treatment: BEHAVIORAL: Compliance Monitoring, OTHER: Laboratory Biomarker Analysis, DRUG: Mercaptopurine, DRUG: Methotrexate, OTHER: Questionnaire Administration, OTHER: Study of Socioeconomic and Demographic Variables Location: Canada, United States, Australia Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Diagnosis of ALL in first remission, irrespective of risk stratification; enrollment on a Children's Oncology Group (COG) therapeutic study for ALL is not required, but the treatment plan must meet the criteria in this protocol * Belongs to one of the four following ethnic/racial categories: African-American, Asian, Caucasian, or Hispanic; below please find definitions for these categories * African-American: includes patients who are African-American or of sub-Saharan black African ancestry * Asian: patients of Asian ancestry, including the following: Asian Indian (subcontinent), Chinese, Japanese, Korean, Native Hawaiian, Guamanian or Chamorro, Pacific Islander, Filipino, Vietnamese, Samoan, Hmong, Cambodian, Thai, Laotian, or Other Asian races * Caucasian: includes White or light-skinned patients of European, North African, or Middle Eastern ancestry * Hispanic: patients of Hispanic ethnicity, including the following: Mexican, Mexican American, Chicano, Cuban, Puerto Rican, or Other Spanish/Hispanic/Latino ethnicity * Receiving self- or parent/caregiver-administered oral anti-metabolite chemotherapy during the maintenance/continuation phase of therapy; patients are eligible if their treatment plan calls for the following doses of 6-MP and methotrexate (MTX) during the maintenance/continuation phase: 6-MP ? 75 mg/m^2/day orally; MTX 20 mg/m^2/week orally;** (modification of 6-MP or MTX dosing based on laboratory or clinical parameters is acceptable) * For guidance regarding if and when a patient being treated on or according to a specific COG (or legacy group) protocol is eligible, please refer to ?AALL03N1 Eligibility by Protocol Tool,? available in the study data forms packet on the COG website * Has completed at least 24 weeks of maintenance/continuation chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance/continuation chemotherapy** * For guidance regarding if and when a patient being treated on or according to a specific COG (or legacy group) protocol is eligible, please refer to ?AALL03N1 Eligibility by Protocol Tool,? available in the study data forms packet on the COG website * Written informed consent from the patient and/or the patient?s legally authorized guardian, obtained prior to registration and any study-related procedures, and in accordance with institutional policies approved by the United States (U.S) Department of Health and Human Services Exclusion Criteria: * Patients of multi-ethnic/multi-racial backgrounds are not eligible for this study; while patients of multi-ethnic/multi-racial ancestry (e.g., Caucasian/Japanese, Hawaiian/Puerto Rican) are not eligible, patients of mixed ancestry within a race/ethnicity (e.g., Japanese/Chinese = Asian or Korean/Japanese/Hawaiian = Asian or Mexican/Puerto Rican = Hispanic) may participate as long as they fall under the general classification of "African-American," "Asian," "Caucasian," or "Hispanic"

NCT_ID NCT00268528

Study_NameStudy to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission

Study Objectives This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome Conditions: Esophageal Adenocarcinoma, Barrett's Esophagus, Reflux Esophagitis Intervention / Treatment: DRUG: Chlorhexidine gluconate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >18 * Scheduled for upper endoscopy for clinical indications * No allergy or other contraindication to chlorhexidine Exclusion Criteria: * Use of proton pump inhibitors or H2 receptor antagonists within 1 month of enrollment. Acid suppressant medications raise the gastric pH and can dramatically alter the gastric and esophageal microbiome. * History of upper gastrointestinal cancer * History of histologically proven Barrett's esophagus * History of antireflux or bariatric surgery, or other gastric or esophageal surgery * Use of antimicrobial mouthwash within 1 month of enrollment * Use of antibiotics or immunosuppressant medications within 3 months of enrollment * Use of steroid inhalers or nasal sprays within 1 month of enrollment * HIV or other immunosuppressed states or conditions (e.g. active malignancy) * Pregnant or breast feeding * Inability to give informed consent

NCT_ID NCT02513784

Study_NameTrial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome

Study Objectives Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors (≥2nd line) (DasaHIT Trial (Dasatinib Holiday for Improved Tolerability)) Conditions: Myeloid Leukemia, Chronic Intervention / Treatment: DRUG: dasatinib (SPRYCEL®) Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph+ chromosome [t(9;22)(q34;q11)]. * Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR4 will be also considered eligible. * ECOG performance status <=2. * Age >= 18 years (no upper age limit is given) * Serum levels of potassium, magnesium and total calcium within the normal limits (>=LLN [lower limit of normal] and <=ULN [upper limit of normal]). Correction of electrolytes' levels with supplements to meet enrolment criteria is allowed. * AST and ALT <=2.5 x ULN or 5.0 x ULN if considered due to leukemia * Alkaline phosphatase <=2.5 x ULN unless considered due to leukemia * Total bilirubin <=1.5 x ULN, except known Gilbert disease * Serum creatinine <=2 x ULN * Written informed consent prior to any study procedures being performed. For 1st-line patients: * Pre-treatment with hydroxyurea up to 6 months and imatinib or dasatinib for duration of up to 4 weeks is permitted. For >= 2nd-line patients: * Patients with treatment failure according to the 2013 ELN Recommendations criteria3 or treatment intolerance as assessed by the investigator after prior treatment with TKIs other than dasatinib (imatinib, nilotinib, bosutinib, ponatinib). Exclusion Criteria: * Previous allogeneic stem cell transplantation (AlloSCT) * Known impaired cardiac function, including any of the following: * Congenital long QT syndrome * History of or presence of clinically significant ventricular or atrial tachyarrhythmia * QTc >450 msec on screening ECG * Myocardial infarction within 6 months prior to starting therapy * Other clinical significant heart disease (e.g. unstable angina pectoris, congestive heart failure) * Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores >6), even if controlled * Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol * Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery) * Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4 * Patients who have undergone major surgery <=2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of dasatinib. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug * Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) * Active autoimmune disorder, including autoimmune hepatitis * Known serious hypersensitivity reactions to dasatinib * Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention * Patients unwilling or unable to comply with the protocol.

NCT_ID NCT02890784

Study_NameDasatinib Holiday for Improved Tolerability

Study Objectives This single center Phase I dose escalation trial will evaluate the safety, tolerability and efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+ overexpression or FISH amplification documented locally. Part 2 will evaluate the safety of the MTD of LBH589 determined in Part 1 when paired with lapatinib 1000 mg by mouth (PO) daily. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+ overexpression or FISH amplification documented locally. Part 3 will evaluate the tolerability and effectiveness of the triplet combination, LBH589, capecitabine and lapatinib in breast cancer patients. Conditions: Breast Cancer Intervention / Treatment: DRUG: LBH589, DRUG: Capecitabine, DRUG: Lapatinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically documented metastatic or locally unresectable, incurable malignancy for which capecitabine is clinically appropriate. * Male or female patients aged >= 18 years. * Maximum of 3 prior regimens in a metastatic setting allowed and may include other targeted agents, immunotherapy and chemotherapy. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. * Baseline MUGA or ECHO must demonstrate LVEF > than the lower limits of the institutional normal. * Laboratory values as follows: * ANC > 1500/μL * Hgb > 9 g/dL * Platelets > 100,000/uL * Bilirubin < 1.5 mg/dL * AST/SGOT < 2.5 x ULN or < 5.0 x ULN and ALT/SGPT in patients with liver metastases * Creatinine < 1.5 mg/dL or calculated creatinine clearance > 50 ml/min * Albumin > 3 g/dL * Potassium > lower limit of normal (LLN) * Phosphorous > LLN * Calcium > LLN * Magnesium > LLN * Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment and must commit to begin two acceptable methods of birth control, one highly effective method of birth control and one additional effective method at the same time before starting treatment. * Life expectancy > 12 weeks. * Accessible for treatment and follow-up. * All patients must be able to understand the nature of the study and give written informed consent prior to study entry. Additional Breast Cancer Patient Subset (Part 2 and Part 3) Inclusion Criteria: * Incurable carcinoma of the breast, with measurable locally recurrent or metastatic disease. * ICH 3+ overexpression or FISH amplification documented by a local laboratory in primary or metastatic tumor tissue. * Prior treatment with an anthracycline, taxane, and trastuzumab or not a candidate for such treatment. Patient may have received these drugs in combination or in sequence for the treatment of locally advanced or metastatic disease and/or adjuvant therapy. Exclusion Criteria: * Prior treatment with an HDAC inhibitor or current treatment with valproic acid. * Previous treatment with capecitabine. * Impaired cardiac function including any of the following: * Screening ECG with a QTc > 450 msec. * Congenital long QT syndrome. * History of sustained ventricular tachycardia. * Any history of ventricular fibrillation or torsades de pointes. * Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate > 50 beats per minute are eligible. * Myocardial infarction or unstable angina within 6 months of study entry. * Congestive heart failure (NY Heart Association class III or IV). * Right bundle branch block and left anterior hemiblock (bifascicular block). * Atrial fibrillation or flutter. * Ongoing therapy with antiarrhythmics or other medications associated with QTc prolongation. * Uncorrected hypokalemia or hypomagnesaemia. * Uncontrolled hypertension (systolic blood pressure [BP] 180 or diastolic BP > 100 mm Hg) or uncontrolled cardiac arrhythmias. * Active CNS disease, including meningeal metastases. * Known diagnosis of human immunodeficiency virus (HIV) infection. * Unresolved diarrhea > CTCAE grade 1. * Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors. * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib. * Patients with known hypersensitivity to 5-fluorouracil chemotherapy, investigational drug therapy, major surgery < 4 weeks prior to starting study drug or patients that have not recovered from side effects of previous therapy. * Patient is < 5 years free of another primary malignancy except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed. * Concomitant use of any anti-cancer therapy or radiation therapy. * Pregnant or breast feeding or female of reproductive potential not using two effective methods of birth control. * Male patients whose sexual partners are women of childbearing potential not using effective birth control. * Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis). * Other concurrent severe, uncontrolled infection or intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients taking any medications listed in "Prohibited Medications" for both capecitabine and lapatinib . * Patients with uncontrolled coagulopathy (PT and/or PTT > 1.2 x ULN; patient must also be on stable dose of anticoagulant for a defined medical indication). * Abnormal thyroid function (TSH or free T4) detected at screening. Patients with known hypothyroidism who are stable on thyroid replacement are eligible. Additional Breast Cancer Patient Subset (Part 2 and Part 3) Exclusion Criteria: * Prior treatment with lapatinib

NCT_ID NCT00632489

Study_NameLBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients

Study Objectives This perspective, mono institutional study is addressed to find potential serum and urine biomarkers predictive of the pharmacokinetic and pharmacodynamic profile of soft tissue sarcomas patients treated with trabectedin. Conditions: Sarcoma Intervention / Treatment: DRUG: Trabectedin Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Advanced Soft Tissues Sarcoma STSs (unresectable and/or metastatic disease). * One previous systemic treatment with ananthracycline ± ifosfamide. * Measurable disease, as defined by RECIST criteria. * ECOG PS <=2. * Age >=18 years. * A minimum of 3 weeks since prior tumor directed therapy * Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower. * Adequate haematological, renal liver function. * Ability and willingness to provide informed consent Exclusion Criteria: * Pregnant or breast-feeding women * Prior exposure to Trabectedin. * Peripheral neuropathy, Grade 2 or higher. * Known CNS metastases. * Active viral hepatitis or chronic liver disease. * Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias. * Active major infection. * Other serious concomitant illnesses.

NCT_ID NCT04394728

Study_NamePharmacometabolomic of Trabectedin in Soft Tissue Patients

Study Objectives RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they work compared with bicalutamide in treating patients with recurrent or metastatic prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Bicalutamide, DRUG: Everolimus Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Participants must be adult males >18 years. * Patients must have histologically or cytologically confirmed CaP with a Gleason score available or interpretable. * Patients must have CaP deemed to be androgen independent. * Measurable disease is not required. * Patients must have been surgically or medically castrated. If the method of castration was LHRH agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists. Serum testosterone must be at castrate levels (< 50 ng/dL) within 3 months prior to registration. * Participant has not been on any previous therapy with androgen receptor antagonists or mTOR inhibitors. Note: patients who have taken an androgen receptor antagonist for a brief period (no more than 2 months) at the start of LHRH agonist therapy to prevent flare will be considered eligible. * Men enrolled in this trial must agree to use adequate contraception prior to study entry and for the duration of study participation. * Patients must have normal organ and marrow function. * Ability to understand and the willingness to sign a written informed consent document * ECOG performance status 0 <= age <= 2. * Patients having any respiratory symptoms such as cough and shortness of breath have undergone pulmonary function testing revealing no worse than mild impairment. Exclusion Criteria * No documented histological confirmation of CaP. * Patient has received other hormonal therapy besides first-line androgen deprivation therapy with LHRH agonist, LHRH antagonist, orchiectomy, high-dose steroid, abiraterone, provenge and ketoconazole. * Patients who have received prior treatment with an mTOR inhibitor. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with RAD001. * Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.) * Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study. * Prior treatment with any investigational drug within the preceding 4 weeks. * Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. * Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. * Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES. * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. * Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other Stage 0 or I cancers. * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001. * Patients with an active, bleeding diathesis. * History of noncompliance to medical regimens. * Patients unwilling to or unable to comply with the protocol. * Patients with active pulmonary disorders or history of moderately to severely impaired pulmonary function tests will be excluded from the study. * Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function or spinal cord compression will be excluded from this study unless these issues have been taken care of.

NCT_ID NCT00814788

Study_NameBicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer

Study Objectives The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone. Conditions: Liver Metastases, Colorectal Cancer Intervention / Treatment: DRUG: Adecatumumab, DRUG: Adecatumumab and FOLFOX, DRUG: FOLFOX 4 Location: France, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histopathologically confirmed complete resection (R0) of liver metastases from colorectal adenocarcinoma * Age >=18 years * ECOG performance status <= 2 * Patient was informed, has read and understood the patient information / informed consent form and has given written informed consent Exclusion Criteria: * Extra-hepatic distant metastases or locally recurrent disease at time of enrolment * Neoadjuvant chemotherapy of liver metastases prior to surgery * Any anticancer chemotherapy within 4 weeks prior to study entry * Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry * Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry * Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery * Treatment with any investigational product within a time range of 4 <= age <= 5 half-lives (t½) prior to study entry * Acute or chronic pancreatitis or history of alcohol induced pancreatitis * Liver cirrhosis, acute hepatitis or chronic hepatic disease * Any unresolved complications from prior surgery * Persistent neuropathy * History of other malignancy within 5 years prior to study start, with the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix and Ductal Carcinoma in Situ (DCIS) * History of inflammatory bowel disease * Active severe infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator * Use of immune-suppressive agents such as the regular use of systemic corticosteroids * HIV positivity * Known hypersensitivity or intolerability to immunoglobulins in general, other recombinant human or humanized antibodies, Folinic Acid, 5-Fluorouracil, Oxaliplatin or a component of the study drug formulations, known dihydropyrimidine dehydrogenase (DPD) deficiency * Pregnant or nursing women * Women of childbearing potential or male patients not willing to use an effective form of contraception during treatment phase of the study and at least 6 months thereafter * Not willing or incapable to comply with all study visits and assessments * Placed into an institution due to juridical or regulatory ruling

NCT_ID NCT00866944

Study_NameStudy of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

Study Objectives The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer Intervention / Treatment: BIOLOGICAL: Nivolumab, DRUG: Gemcitabine, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Paclitaxel, DRUG: Pemetrexed Location: Poland, United Kingdom, Australia, Austria, France, Korea, Republic of, Netherlands, Greece, Canada, Turkey, Finland, Germany, Sweden, Spain, Czechia, Italy, Taiwan, Romania, Switzerland, Argentina, United States, Brazil, Japan, Belgium, Mexico, Hungary Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <= 1 * Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria * PD-L1+ on immunohistochemistry testing performed by central lab * Men and women, ages >= 18 years Exclusion Criteria: * Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy * Known anaplastic lymphoma kinase (ALK) translocations * Untreated central nervous system (CNS) metastases * Previous malignancies * Active, known or suspected autoimmune disease

NCT_ID NCT02041533

Study_NameAn Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

Study Objectives Skin cancers and pre-cancerous growths (called actinic keratoses, "AKs"), that aren't melanomas, develop in patients with a kidney transplant at excessive rates. When these pre-cancerous AKs, and "non-melanoma" skin cancers occur in kidney transplant patients, they tend to be aggressive, and require frequent medical procedures, often surgery, for the removal of the skin cancers. If not removed adequately the pre-cancers can develop into skin cancers, and the skin cancers, if not removed, may spread, and even cause death. Reducing the occurrence and complications of these skin cancers and pre-cancers in kidney transplant patients with a safe, effective, well-tolerated treatment taken by mouth would be an important medical advance. We are testing oral nicotinamide (NAM)-a B-vitamin compound-for that purpose. Approximately fifty kidney transplant patients who have had at least one non-melanoma skin cancer in the past, will be given randomized to receive NAM, 1 gram twice daily by mouth, or identical pills without NAM, and followed for 1 year to see if NAM treatment reduces the numbers of pre-cancerous AKs, and non-melanoma skin cancers they develop. Patients will be asked to come to the clinic for 3 follow up visits (every 4 months for up to 12 months). They will receive a full body skin exam by a dermatologist, have detailed counting of AKs and biopsies for any suspicious lesions as standard of care. Blood will also be drawn as well as a urine sample obtained at each visit for safety assessment and storage. We will also ask them to answer a series of questions about dietary patterns and intake of whole foods and supplements. Conditions: Actinic Keratoses Intervention / Treatment: DRUG: Oral Nicotinamide Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Kidney transplant >= 12-months ago * ongoing, standard immunosuppression regimen * current CKD * EPI estimated (43) * glomerular filtration rate (eGFR) >= 15 ml/min per 1.73 m2) * Prior history of at least one NMSC Exclusion Criteria: * Kidney transplant <12-months ago, treatment for acute rejection <= 3-months ago, or current eGFR< 20 * Known history of active liver disease/ transaminitis [alanine aminotransferase, ALT > 1.5 X upper limit of normal] * Serum phosphorus < 2.0 mg/dL or average <= 100 × 10(9)/mL platelets * Internal malignancy, metastatic SCC, or invasive melanoma within the past 5-years * Overwhelming numbers of current skin cancers or large areas of confluent skin cancer at baseline preventing accurate assessment and counting of new skin cancers * Field treatment for AKs within the past 4-weeks, preventing accurate assessment of AKs * Patients begun on acitretin or other oral retinoids, or mTOR inhibitors within the past 6-months (If stably taking for more than six months, they may participate) * Gorlin's syndrome or other genetic skin cancer syndrome * Patients unavailable for follow-up for the duration of the study because of social/ geographical reasons, or general frailty * Pregnancy or lactation (all women of childbearing will be required to use contraception throughout the study) * Patients taking supplemental NAM within the past 4-weeks

NCT_ID NCT04843553

Study_NameNicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients

Study Objectives The purpose of the study is to learn about the safety and effectiveness of treating follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT) using 90-yttrium (Y) ibritumomab tiuxetan. The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to the study treatment. Bendamustine is approved by the United States Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat follicular lymphoma. Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma. 90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular NHL. It is also approved for the treatment of follicular NHL that is previously untreated with radioimmunotherapy and that achieved a partial or complete response to first-line chemotherapy. Study participants will will receive bendamustine and rituximab for up to 16 weeks. If participants' cancer responds well to the treatment with bendamustine and rituximab, they will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete, participants will be asked to return to the clinic every 3 months for a maximum of 10 years for follow-up visits. Conditions: Lymphoma, Follicular Intervention / Treatment: DRUG: Bendamustine, DRUG: Rituximab, RADIATION: Y-90 ibritumomab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Previously untreated, histologically confirmed follicular lymphoma classification grade 1, 2 or 3a * Ann Arbor stages of II to IV with either symptomatic or bulky disease (>5 cm); or disease progression * 18 years or older * ECOG PS <2 * Normal organ and marrow function defined as below: Absolute neutrophil count (ANC) >= 1,000/mm3 Platelet count >=100,000/mm3 Patients with ANC less than 1,000/mm3 and/or platelets below 100,000/mm3 are still eligible for study entry as long as there is >50% bone marrow involvement with lymphoma * Adequate hepatic function * Adequate renal function * Measureable disease with at least one lesion measuring > 2cm in its greatest transverse diameter * Female subjects of childbearing potential must have a negative pregnancy test (urine or serum b-HCG) at screening and within 1 week prior to the start of treatment with Y-90 ibritumomab tiuxetan * Voluntary written informed consent must be given before performance of any study-related procedure Exclusion Criteria: * Prior chemotherapy, immunotherapy, or monoclonal antibody therapy * Receiving any other investigational agents * Primary CNS lymphoma * Known HIV * Treatment with therapeutic doses of systemic steroids within 4 weeks of beginning study treatment (cycle 1, day -7); topical use of corticosteroids and systemic replacement of corticosteroids for adrenal insufficiency are allowed * Malignant pleural, pericardial or peritoneal effusions * Known history of myelodysplastic syndrome (MDS) or found to have MDS * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would, in the judgment of the investigator, limit compliance with study requirements * Pregnant or lactating female subjects * Concurrent active malignancy other than lymphoma or history of invasive malignancy within the past 5 years, except completely excised, non-melanoma skin cancer * Known Hepatitis B and/or Hepatitis C Infection * Any other condition, that in the judgment of the investigator places the patient at unacceptable risk if he/she were to participant in the study

NCT_ID NCT01234766

Study_NameBendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma

Study Objectives Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have myelofibrosis. Imatinib mesylate may stop the growth of myelofibrosis by blocking certain enzymes necessary for cell growth. Conditions: Chronic Myelomonocytic Leukemia, Essential Thrombocythemia, Polycythemia Vera, Primary Myelofibrosis Intervention / Treatment: DRUG: imatinib mesylate, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologic confirmation of one of the following diseases- * Myeloid metaplasia with myelofibrosis (this includes all subtypes- chronic idiopathic myelofibrosis or agnogenic myeloid metaplasia, post thrombocythemic and post polycythemic myelofibrosis) or * Chronic myelomonocytic leukemia (CMMOL) with t(5;12)(q31 <= age <= 33;p12) or TEL-PDGFRβ rearrangement; patients with CMMOL and the t(5;7)(q31 <= age <= 33;q11.2) or other chromosomal translocations resulting in activation of PDGFR will also be eligible * Patients must have anemia (hemoglobin < 11 g/dL) or palpable splenomegaly (measured in cm from costal margin- to eligible); patients with palpable splenomegaly must have spleen size documented ultrasonographically as well; they must also meet standard diagnostic criteria for MMM* or CMMOL; patients with MMM must have thrombocytopenia (platelet count < 100 x 10^9/L) to be eligible; they must be Philadelphia chromosome or (BCR/ABL) rearrangement negative * Patients with CMMOL must also have the t(5;12)(q31 <= age <= 33;p12) or TEL-PDGFRβ rearrangement to be eligible * The Italian diagnostic criteria for MMM * Necessary criteria * Diffuse bone marrow fibrosis * Absence of the Philadelphia chromosome or BCR-ABL rearrangement in peripheral blood cells * Optional criteria * Splenomegaly of any grade * Anisopoikilocytosis with tear drop erythrocytes * Presence of circulating immature myeloid cells * Presence of circulating erythroblasts * Presence of clusters of megakaryoblasts and anomalous megakaryocytes in bone marrow sections * Myeloid metaplasia * Diagnosis of MMM is acceptable if the following combinations are present * The two necessary criteria plus any other two optional criteria when splenomegaly is present OR * The two necessary criteria plus any other four optional criteria when splenomegaly is absent * Patients may have had prior chemotherapy or radiation therapy including splenic irradiation; prior therapy with erythropoietin, GCSF or androgenic steroids is also permitted; there is no limit to number of prior regimens received; at least 4 weeks must have elapsed since prior chemo, radiation or other therapy * ECOG performance status =< 2 (Karnofsky >= 60%) * Total bilirubin < 1.5 X institutional upper limit of normal * AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal unless due to disease * Serum creatinine < 2 X institutional upper limit of normal * Patients must not be pregnant or nursing because STI-571 at the recommended therapeutic dose may be harmful to the developing fetus or newborn; for this reason women of child-bearing potential and men must agree to use an effective contraceptive method; women of reproductive potential must have a negative pregnancy test within 7 days prior to registration; since interactions with oral contraceptives cannot be excluded at present, male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug * Ability to understand and the willingness to sign a written informed consent document * World Health Organization (WHO) diagnostic criteria for CMMOL: * Persistent peripheral blood monocytosis > 1 x 10^9/L * Absence of the Philadelphia chromosome or BCR/ABL fusion gene * Fewer than 20% blasts in the blood or bone marrow * Dysplasia in one or more myeloid lineages; if myelodysplasia is absent or minimal, the diagnosis of CMML may still be made if the other criteria (1 <= age <= 3) are met and: * An acquired clonal cytogenetic abnormality is present in the marrow cells * The monocytosis has been persistent for at least 3 months * Other causes for monocytosis have been excluded Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients may not be receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to STI-571 * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because STI-571 is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with STI-571, STI-571 should not be administered patients who are breastfeeding * HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with STI-571; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated * Because warfarin is metabolized through the CYP450 system, and since gastrointestinal bleeding may occur with STI-571, no therapeutic anticoagulation with warfarin will be permitted in patients participating in this study; as an alternative, therapeutic anticoagulation may be accomplished using low-molecular weight heparin (e.g. Lovenox) or heparin

NCT_ID NCT00039416

Study_NameImatinib Mesylate in Treating Patients With Myelofibrosis

Study Objectives This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids. Conditions: Heavy Uterine Bleeding, Uterine Fibroids Intervention / Treatment: OTHER: Elagolix placebo, DRUG: Elagolix, DRUG: 0.5 mg estradiol / 0.1 mg norethindrone acetate, DRUG: 1 mg estradiol / 0.5 mg norethindrone acetate, DRUG: E2/NETA placebo Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Subject is pre-menopausal female 18 <= age <= 51 of age at Screening. * Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound. * Subject has heavy uterine bleeding associated with uterine fibroids. Exclusion Criteria: * Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening. * Subject has a history of osteoporosis or other metabolic bone disease. * Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide. * Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy

NCT_ID NCT01817530

Study_NameSafety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Study Objectives This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Erlotinib, DRUG: PF-00299804 Location: Poland, United States, Brazil, Australia, Spain, Singapore, United Kingdom, Taiwan, Puerto Rico, Canada, Korea, Republic of, Hong Kong Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * advanced measurable Non-Small Cell Lung Cancer (NSCLC); * progressed after 1 <= age <= 2 prior chemotherapy; * Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 2; * tissue available for future KRAS/ EGFR testing Exclusion Criteria: * prior Epidermal Growth Factor Receptor (EGFR) targeted therapy; * active or untreated Central Nervous System (CNS) metastases;

NCT_ID NCT00769067

Study_NameA Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Study Objectives The purpose of this study is to learn the effects (both good and bad) that celecoxib has on prostate cancer and patients with prostate cancer. This study is looking at what effects celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate cancer. An increase or decrease in this level in the blood can indicate if a patient's prostate cancer is getting worse or better. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Celecoxib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: DOUBLE

Inclusion Criteria: * Diagnosis of prostate cancer * Progression following prostatectomy or radiation to the prostate, defined as 3 PSA rises, with each PSA determination at least 4 weeks apart * PSA greater than or equal to 1.0 for men who had a prostatectomy * PSA greater than or equal to 3.0 for men who were treated with primary radiation therapy (external beam and/or brachytherapy) * PSA doubling time between 6 and 24 months * Participants must be either fully active and asymptomatic or symptomatic but fully ambulatory * Adequate bone marrow function, kidney function and liver function as evidenced by laboratory results Exclusion Criteria: * Evidence of metastatic disease * Prior hormonal therapy for recurrent prostate cancer * Prior chemotherapy for recurrent or metastatic prostate cancer * Radiation therapy within 6 months * Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs), salicylates or sulfonamide-type medications who experience asthma or urticaria (hives) after taking aspirin or other NSAIDs * Patients taking a dose of aspirin greater than or equal to 325 mg a day within 4 weeks of study entry * Patients taking selective COX-2 inhibitors or any NSAIDs other than aspirin within 8 weeks of study entry * Patients taking fluconazole, lithium or warfarin * History of gastrointestinal or abdominal ulceration or any history of significant gastrointestinal bleeding in the past 12 months * Any history of myocardial infarction in the past 12 months * Any uncontrolled, serious medical or psychiatric illness

NCT_ID NCT00136487

Study_NameCelecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer

Study Objectives Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of safety, tolerability and preliminary therapeutic effects of \[14C\]volasertib in patients with advanced solid tumours. Conditions: Neoplasms Intervention / Treatment: DRUG: BI 6727 Location: Hungary Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Inclusion Criteria 1. Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid tumour * Inclusion Criteria 2. Male * Inclusion Criteria 3. Age >=18 and =<70 years * Inclusion Criteria 4. Written informed consent * Inclusion Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance score =<2 * Inclusion Criteria 6. Recovery from Common Terminology Criteria for Adverse Events (CTCAE) Grade >=2 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapy Exclusion criteria: * Exclusion Criteria 1. Serious concomitant non-oncological disease considered by the investigator * Exclusion Criteria 2. Active infectious disease * Exclusion Criteria 3. Viral hepatitis, Human Immunodeficiency Virus (HIV) infection * Exclusion Criteria 4. Clinical evidence of active brain metastasis during the past 6 months * Exclusion Criteria 5. Second malignancy currently requiring active therapy * Exclusion Criteria 6. Absolute neutrophil count less than 1,500/mm3 * Exclusion Criteria 7. Platelet count less than 100,000/mm3 * Exclusion Criteria 8. Total bilirubin greater than 1.5 mg/dL * Exclusion Criteria 9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) * Exclusion Criteria 10. Serum creatinine greater than 1.5x Upper Limit of Normal (ULN). * Exclusion Criteria 11. Known history of QT/QTcF-prolongation * Exclusion Criteria 12. Patients who are sexually active and having a partner with childbearing potential and unwilling to use a medically acceptable method of contraception * Exclusion Criteria 13. Treatment with other investigational drugs or participation in another clinical trial * Exclusion Criteria 14. Chemo-, radio- immuno-, or molecular-targeted cancer-therapy within the past four weeks prior to start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates. * Exclusion Criteria 15. Alcohol abuse * Exclusion Criteria 16. Life expectancy less than 12 weeks * Exclusion Criteria 17. Potent Cytochrome P450 enzyme (CYP) 3A4 and P-glycoprotein inhibitors or inducers * Exclusion Criteria 18. History of allergy/hypersensitivity

NCT_ID NCT01145885

Study_NameBI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours

Study Objectives In this study it will be determined whether the rate of severe toxicity associated with fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront genotypic assessment of dihydropyrimidine dehydrogenase (DPD) deficiency. In addition to the genotyping, the DPD phenotype of all patients will be determined by measuring the baseline dihydrouracil/uracil (DHU/U) ratio, in order to investigate whether phenotype-guided treatment can further improve patient safety. In a subgroup of patients, other phenotyping methods will be tested: measuring the plasma levels of uracil after a uracil test dose and a uracil breath test after a dose of \[2-13C\] -labeled uracil. To validate these tests, these phenotyping results will be compared with the results of a DPD activity assay (which measures DPD enzyme activity in peripheral blood mononuclear cells), which is considered the gold standard in measuring DPD phenotype. Conditions: Neoplasms Intervention / Treatment: DRUG: Fluoropyrimidine (capecitabine or 5-fluorouracil) Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient's best interest * Age >= 18 years * Able and willing to give written informed consent * WHO performance status of 0, 1 or 2 * Life expectancy of at least 12 weeks * Able to swallow and retain oral medication * Able and willing to undergo blood sampling for pharmacogenetic and phenotyping analysis * Minimal acceptable safety laboratory values (ANC, platelet count, hepatic function, renal function) Additional inclusion criteria for patients in subgroup of study: * Able and willing to undergo blood sampling and breath sampling at several time points * Able and willing to receive uracil for the test dose assay * Able and willing to receive [2 <= age <= 13C] -labeled uracil for the breath test Exclusion Criteria: * Prior treatment with fluoropyrimidines * Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety * Women who are pregnant or breast feeding * Both men and women who refuse to use reliable contraceptive methods throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms) * Patients with a homozygous polymorphic genotype or compound heterozygous genotype for DPYD

NCT_ID NCT02324452

Study_NameSafety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines

Study Objectives The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer. Additionally, this study will evaluate the safety and tolerability of entinostat in combination with exemestane, and assess the effectiveness of entinostat in combination with exemestane in terms of best overall response and overall survival. Conditions: Breast Cancer, Estrogen Receptor Positive Breast Cancer Intervention / Treatment: DRUG: entinostat, DRUG: exemestane Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Postmenopausal female patients * Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and have locally recurrent or metastatic disease that has progressed to where the patient is a candidate to receive exemestane as determined by the Investigator * Patients receiving palliative radiation at the non-target lesions must be clinically stable prior to receiving the first dose of study treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient must have acceptable, applicable laboratory requirements * Patients may have a history of brain metastasis provided certain protocol criteria are met * Able to understand and give written informed consent and comply with study procedures Exclusion Criteria: * Rapidly progressive or life-threatening metastases * Inability to swallow oral medications or gastrointestinal (GI) malabsorption syndromes * History of significant GI surgery as determined by Investigator * A medical condition that precludes adequate study treatment or increases patient risk * Currently enrolled in (or completed within 30 days prior to study drug administration) another investigational drug study

NCT_ID NCT02820961

Study_NameDrug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

Study Objectives The purpose of this study is to find out if complementary and alternative medicines (CAM) should be included with traditional therapy for women with ovarian cancer. Some of the alternative medicines include non-traditional drug and herbal therapies along with dietary and nutritional strategies. Only a few of these alternative medicines have been tested with women with ovarian cancer. Conditions: Ovarian Cancer Intervention / Treatment: OTHER: Pre-study Questionnaire, OTHER: Educational Presentations, OTHER: CAM Therapies, OTHER: Post-study Questionnaire Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * A diagnosis of ovarian cancer * An Eastern Cooperative Oncology Group (ECOG) score of 2 or less with a life expectancy of at least 12 months * A patient being treated by a gynecologic oncologist in the Center for Women's Oncology * Ability to read, understand, and sign the informed consent form * Ability to read, write and understand English, which will be the language used in the materials and oral presentations * Willingness to complete pre-test and post-test questionnaires * Willingness to complete brief questionnaires at each session * Willingness to participate in one follow-up telephone interview at 8 weeks after the final session * Willingness to participate in four sessions that take place at Moffitt Cancer Center * Access to transportation, with the ability to travel to and from Moffitt to participate in the sessions

NCT_ID NCT01419210

Study_NamePilot Program to Personalize Care & Improve Quality of Life for Women With Ovarian Cancer

Study Objectives Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy. Conditions: Neoplasms, Prostate Intervention / Treatment: DRUG: dutasteride, DRUG: placebo, DRUG: bicalutamide Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion criteria: * Men >=40 and <=90 years * Must have asymptomatic prostate cancer that has progressed during androgen deprivation therapy (rising PSA). PSA progression must have occurred after first-line treatment with GnRH analogues ( e.g. leuprolide, goserelin) or orchiectomy. PSA progression is defined by three rises in PSA each measured at least 4 weeks apart within the previous year. * Serum PSA >=2 and <=20ng/ml from central laboratory. One PSA retest from central laboratory is allowed if the value is <2 or >20ng/ml; or if the PSA value is not consistent with the previous rising PSA values that determined progression while on a GnRH analogue. * Serum Testosterone <50ng/ml from central laboratory. * Non-metastatic prostate cancer as confirmed on prior bone scan performed within 8 weeks of screening. * Expected survival >= 2 years * ECOG Performance status 0, 1, or 2 Exclusion criteria: * Additional hormonal therapy (excluding the current use of a GnRH analogue) within the past 6 months of: * Estrogens (e.g. megestrol, medroxyprogesterone, cyproterone, DES) * Drugs with antiandrogenic properties (e.g., spironolactone if >50mg/day, flutamide, bicalutamide*, ketoconazole**, progestational agents) *The use of an antiandrogen during GnRH analogue induction for <6 weeks is acceptable, but none within the 3 months prior to study entry. **The use of topical ketoconazole is permitted prior to and during the study. NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto), excluding daily vitamins, during the study is discouraged, but not prohibited. All dietary and herbal supplement usage will be recorded in the eCRF. * Treatment with oral glucocorticoids during the 3 months prior to randomization or expectation of their use during the study. * Prior chemotherapy for prostate cancer. (prior prostatectomy or radiotherapy to the prostate are allowed) * Prostate surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and cryosurgical ablation within 2 months prior to enrollment. * Current and/or previous use of the following medications: * Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry * Anabolic steroids (within 6 months prior to study entry) * Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period. * Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes; or peptic ulcer disease which is uncontrolled by medical management. * Abnormal liver function test greater than 1.5 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP] or bilirubin. * Serum creatinine >2.0 times the upper limit of normal. * History of another malignancy within five years that could affect the treatment of prostate cancer or survival of the subject. * History or current evidence of drug or alcohol abuse within the last 12 months. * History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject. * Known hypersensitivity to any 5 alpha-reductase inhibitor or to any drug chemically related to dutasteride.

NCT_ID NCT00470834

Study_NameProstate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

Study Objectives Primary: * To assess complete pathological response rate of both strategies. Secondary: * Safety profile * To assess downstaging rate of both strategies. * To compare relative dose intensity of oxaliplatin and capecitabine of both strategies * To compare time to progression and overall survival of both strategies. Conditions: Rectal Neoplasms Intervention / Treatment: DRUG: Oxaliplatin, capecitabine, DRUG: Oxaliplatin, capecitabine Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with rectal adenocarcinoma. * Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or, * Rectal tumour at distal third, or * Tumours spread more than 5 mm in perirectal fat * Functional state ECOG <= 2. * Good hematological, hepatic and renal function Exclusion Criteria: * Previous pelvis radiotherapy. * Previous antitumoural chemotherapy * Pregnant or breastfeeding women. * Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months. * History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer. * Clinically significant cardiovascular disease * Confirmed peripheral neuropathy. * Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication. * Blood disorders. * Intercurrent non-controlled or severe infections. * Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

NCT_ID NCT00421824

Study_NameStudy of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

Study Objectives This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter. Conditions: Carcinoma, Renal Cell Intervention / Treatment: DRUG: pazopanib Location: Poland, United Kingdom, Australia, Austria, Lithuania, Tunisia, Korea, Republic of, Chile, Pakistan, China, Slovakia, Estonia, New Zealand, Ukraine, Czech Republic, Italy, Argentina, Brazil, Latvia, Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Progressed from VEG105192 study treatment * Patient's VEG105192 was placebo * Baseline has good organ function Exclusion criteria: * No brain metastasis

NCT_ID NCT00387764

Study_NameExtension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer

Study Objectives We conducted a randomized controlled trial of adjuvant interferon (IFN) therapy in patients with hepatitis-C virus (HCV)-related cirrhosis who underwent curative resection of hepatocellular carcinoma (HCC) to investigate whether IFN could reduce or delay the incidence of recurrent tumor (secondary/tertiary prevention of HCC). Patients were randomly assigned to treatment with IFN (3MU thrice/wk /48 weeks) vs. no treatment after curative resection of HCC(control group) Conditions: Hepatocellular Carcinoma, Hepatitis C Virus Infection, Liver Cirrhosis, Interferon Treatment, Hepatic Resection Intervention / Treatment: DRUG: Interferon alpha-2b Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * HCV-RNA positive / HBsAg-negative patients with HCC undergoing potentially curative resection * Curative surgery (i.e. no residual tumor intraoperative US and tumor-free margins at pathology) * No recurrence 1 month after surgery (CT, NMR, US) * Pre-resection treatments allowed (TACE, RFA, PEI) * HCV-RNA positive (lower limit of detection: 100 copies/ml) regardless of blood titers or genotype Exclusion Criteria: * HBsAg-positivity * Evidence of any active neoplastic site * Previous IFN or chemotherapy or treatment of other tumors * Severe surgical complication and/or causes of cirrhosis not related to HCV * Patient comorbidity (Hb <12 g/dl, HIV infection, autoimmune disease, psychiatric disorder, seizure, severe cardiovascular disease, poorly controlled diabetes, BMI >35) * Active alcohol intake (>80 g/day)

NCT_ID NCT00273247

Study_NameTreatment With IFN After Curative Resection of HCC in HCV-Related Cirrhosis

Study Objectives This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small amounts of radioactivity and CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with fluciclovine F18 in helping find out how far the prostate cancer has spread. Conditions: Recurrent Prostate Carcinoma Intervention / Treatment: PROCEDURE: Computed Tomography, DRUG: Fluciclovine F18, DRUG: Gallium Ga 68-labeled PSMA-11, OTHER: Laboratory Biomarker Analysis, PROCEDURE: Positron Emission Tomography Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histopathologically proven prostate cancer (PCa) * Radical prostatectomy as definitive treatment for PCa * Proven biochemical recurrence as defined by American Urological Association (AUA) recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after radical prostatectomy * PSA values ranging from 0.2 ng/mL to 2 ng/mL * No prior salvage therapies (including salvage radiotherapy and/or salvage lymph node dissection) * Axumin PET/CT scan already performed or scheduled as best standard of care procedure for suspected disease relapse within 2 weeks before or after intended 68Ga-PSMA-11 PET/CT * Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization [WHO] equivalent) * Ability to understand a written informed consent document and the willingness to sign it Exclusion Criteria: * Any change in prostate cancer treatment between Axumin and 68Ga-PSMA PET/CT scan * Unable to lie flat, still or tolerate a PET scan

NCT_ID NCT03515577

Study_NameGallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery

Study Objectives In this study, the investigators designed a treatment regimen including the most active agents in pancreatic cancer which are gemcitabine and fluorouracil to be tested as a first line treatment. This regimen is expected to be less toxic than FOLFIRINOX and aiming at better outcomes. Conditions: Cancer of Pancreas, Chemotherapy Effect, Metastatic Pancreatic Cancer Intervention / Treatment: DRUG: Gemcitabine fluorouracil Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histopathological evidence of adenocarcinoma of the pancreas * Radiological proof of metastatic disease as defined by AJCC Exclusion Criteria: * patients with poor performance status (ECOG 4) * patients with organ dysfunction defined as: creatinine more than 1.6 mg/dl or bilirubin more than 3 mg/dl * patients with end stage renal disease who are under regular dialysis * other histologies of pancreatic cancer * irresectable pancreatic cancer if not metatatic

NCT_ID NCT04769414

Study_NameFlouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

Study Objectives This study aimed to provide vast clinical information to facilitate breast sonographic examination for participants who underwent recent SARS-CoV-2 vaccination. Among different SARS-CoV-2 vaccines in the Asian Taiwanese population, reactive axillary lymphadenopathy was investigated through breast sonographic findings and clinical data analysis. The sample included participants with recent vaccinations by different brands approved in Taiwan. Conditions: Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population Intervention / Treatment: BIOLOGICAL: the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine. Location: Taiwan Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * female patients receiving breast sonography Exclusion Criteria: * receive Covid 19 vaccine other than AZ, BNT, Moderna * Ongoing primary breast malignancy * History of malignancy other than primary breast malignancy

NCT_ID NCT06429020

Study_NameSonography for COVID-19 Vaccines Related Reactive Lymphadenopathy

Study Objectives This phase I/II trial is studying the side effects and best dose of vorinostat when given together with paclitaxel and bevacizumab and to see how well they work in treating patients with metastatic breast cancer and/or breast cancer that has recurred in the chest wall and cannot be removed by surgery. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with paclitaxel and bevacizumab may kill more tumor cells. Conditions: Male Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer Intervention / Treatment: DRUG: vorinostat, DRUG: paclitaxel, BIOLOGICAL: bevacizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * histologically or cytologically confirmed adenocarcinoma of the breast; effective with version 2.2 (1/26/09), only patients with disease that is accessible to biopsy and consent to serial biopsy are eligible * stage IV disease, locally recurrent inoperable chest wall disease; at least one bidimensional and/or unidimensional, measurable indicator lesion must be present (patients with only non-measurable disease are eligible for the phase I trial only); all sites of disease should be noted and followed * ECOG performance status =< 1 (Karnofsky >= 70%) * Absolute neutrophil count >= 1,500/ul * Platelets >= 100,000/ul * Total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal * PTT and either INR or PT < 1.5 x normal * Creatinine within normal institutional limits OR creatinine clearance >= mL/min/1.73 m^2 for patients with creatinine levels above institutional normal * Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment; * LVEF must be at or above the lower institutional limit of the normal range (on MUGA or Echo obtained within 12 weeks of registration, or within 4 weeks of prior Herceptin) * Not pregnant/lactating Exclusion criteria: * chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study * may not be receiving any other investigational agents. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in the study (e.g., paclitaxel, bevacizumab, quinolones) * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

NCT_ID NCT00368875

Study_NamePhase I-II Study of Vorinostat, Paclitaxel, and Bevacizumab in Metastatic Breast Cancer

Study Objectives CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: lenalidomide, DRUG: dexamethasone Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects with previously treated multiple myeloma * Measurable levels of m-protein in serum >= 0.5 g/dL [5g/L]) or urine (>= 0.2 g excreted in a 24-hour collection sample) * ECOG performance status of 0 - 2 * Willing to follow pregnancy precautions Exclusion Criteria: * Patients with acute an myocardial infarction (MI) within the past 6 months, or patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 3 years * Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases * Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma * Patients with posterior subcapsular cataracts * Patients with mental illness * Patients with past histories or complications which make the Investigator or other staff member deem them inappropriate for this study * Pregnant or lactating females * Grade 2 or worse neuropathy * Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,000cells/mL Platelet count < 75,000/mL Serum creatinine > 2.5 mg/dL Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) * Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years. - Patients who received radiation therapy within 14 days of the start of study drug * Patients with scars from a recent viscus operation * Patients with history of a desquamating (blistering) rash while taking thalidomide * Patients with prior use of lenalidomide * Patients with known HIV positivity. * Patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of MM within 28 days of the start of lenalidomide therapy. * Patients with known history of hypersensitivity to dexamethasone.

NCT_ID NCT00555100

Study_NameSafety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

Study Objectives Patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented isolated CNS relapse or CNS relapse combined with other relapse sites should receive therapy with intrathecal DepoCyte at least once. Treatment may be repeated during induction phase each 2 weeks and monthly during maintenance phase. The study aim is to replace the usual 2-3 weekly applications of intrathecal triple therapy with one application of DepoCyte. Primary objective is the response rate after one application of DepoCyte. Further objectives are the compilation of data regarding safety and toxicity Conditions: Adult Acute Lymphocytic Leukemia Intervention / Treatment: DRUG: Depocyt, DRUG: Dexamethasone Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * proven diagnosis of ALL or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse * CNS involvement demonstrated by a positive ventricular or lumbar CSF cytology or characteristic signs and symptoms of neoplastic meningitis plus an MRI or CT scan indicating the presence of meningeal involvement * in combined relapse in CNS and other locations: systemic therapy with CNS active drugs can be postponed for at least 2 weeks * Karnofsky Performance Score is > or = 60% * 18 years or older * free of uncontrolled infection * recovered from any grade III / IV toxicities attributable to prior treatment with the exception of hematotoxicity * patient not pregnant or breast feeding and effective methods to prevent pregnancy * free from severe heart, lung, liver or kidney dysfunction * written informed consent Exclusion Criteria: * failed to respond (as defined by no clearance of the CSF) to > 1 dose of prior i.th. MTX or ARAC or triple therapy * history of neurotoxicity (grade III - IV) attributed to i.th. or systemic HD therapy with MTX or ARAC * prior CNS relapse < 1 month before

NCT_ID NCT00199108

Study_NameTreatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt

Study Objectives Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced chondrosarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of two Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated chondrosarcoma. Conditions: Efficacy, Toxicity, Drug Intervention / Treatment: DRUG: Apatinib Mesylate Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 1) histologically confirmed high-grade sarcoma; * 2) initial treatment in the orthopedic oncology departments of the two affiliated hospitals of Peking University; * 3) tumors not amenable to curative treatment or inclusion in clinical trials; * 4) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy; * 5) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) ; * 6) Eastern Cooperative Oncology Group performance status 0 or 1; * 7) acceptable hematologic, hepatic, and renal function. Exclusion Criteria: * had central nervous system metastasis; * had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia; * had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein >= ++ and so on; * had pleural or peritoneal effusion that needs to be handled by surgical treatment; * combined with other infections or wounds; * pregnant or breastfeeding.

NCT_ID NCT04260113

Study_NameApatinib for Inoperable Advanced Chondrosarcoma

Study Objectives This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab. The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB The study has also other secondary and tertiary objectives. Conditions: Breast Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Trastuzumab Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. * Pathologically confirmed carcinoma of the breast. * Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone. * HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (DAKO) 3+ or gene namplification detected by FISH. HER2-positive primary tumours with HER2-negative metastasis can be included. * Disease progression during or after previous chemotherapy and trastuzumab treatment as follows (Trastuzumab has to be given previously for at least 12 weeks, treatment free interval of trastuzumab for a maximum of 6 weeks): * Taxanes + trastuzumab given as adjuvant therapy * Taxanes + trastuzumab given as first line therapy for palliation * Trastuzumab given as first line therapy for palliation alone or in combination with chemotherapeutic agents other than capecitabine or taxanes * No more than 1 chemotherapy for palliation (max. Adriamycin dose < or = 400 mg/m²; Epirubicin < or = 600 mg/m²) * Patients must have either measurable or nonmeasurable target lesions according to the RECIST criteria (see Appendix 6) * At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease * At least 4 weeks since major surgery with full recovery. * Complete radiology and tumor measurement work up within 4 weeks prior to registration: * Karnofsky performance status evaluation > or = 60% * Age >18 years. * Absolute neutrophil count > or =1,500 cells/microL, platelet count > or =100,000 cells/microL. * Bilirubin < or = 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase < 2.5x ULN or <5x ULN for patients with liver metastases. * Creatinine < or = 2.0 mg/dl. * Left ventricular ejection fraction (LVEF) by cardiac ultrasound of > or = 50%. * If of childbearing potential, pregnancy test is negative. In addition the patient agrees to use an effective method to avoid pregnancy for the duration of the study. Exclusion criteria: * Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency. * Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued. * Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and of all steroids. * Life expectancy of less than 3 months. * Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including severe pulmonary conditions, AIDS and serious active infection). * History of congestive heart failure or other significant uncontrolled cardiac disease. * History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer. * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. * Treatment with sorivudine or derivates e.g. brivudin * Pregnant or nursing women. * Male patients. * The patient must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre which could be the Principal or Co- investigator's site.

NCT_ID NCT00148876

Study_NameTBP Study With Capecitabine Plus Minus Trastuzumab

Study Objectives BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This study will be designed to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive solid tumors using continuous daily dosing schedule. Conditions: Cancer Intervention / Treatment: DRUG: GSK2118436 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to standard therapies or for which there is no approved or curative therapy. * Subjects must have BRAF V600E or K mutant positive tumors. * Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication. * Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication. * Must have adequate organ function. * Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 <= age <= 1. Exclusion Criteria: * Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery). * Use of an investigational anti-cancer drug within 28 days preceding the first dose of GSK2118436. * A history of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * History of Human Immunodeficiency Virus (HIV) infection. * Certain cardiac abnormalities. * Pregnant or lactating female.

NCT_ID NCT01582997

Study_NameA Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of of GSK2118436 in Japanese Subjects With BRAF Mutation Positive Solid Tumors

Study Objectives The purpose of this study is to determine whether Bendamustine in combination with Etoposide, Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT in patients with aggressive lymphoma. Conditions: Bendamustine, Conditioning Therapy, Autologous Stem Cell Transplant, Aggressive Non Hodgkin's Lymphoma Intervention / Treatment: DRUG: Bendamustine-EAM Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients being able to meet all requirements of the clinical trial, according to the investigator's criteria, * Patient giving voluntarily written informed consent before performing any essay test that is not part of routine care of patients. * Age >o=18 years and >0=70 years * Candidate for chemotherapy (QT) at high doses and ASCT 1. Histologically confirmed aNHL: 2. Patients with DLBCL or grade 3 b Follicular lymphoma or PTCL (including anaplastic ALK +) in sensitive relapse, so, in second complete or partial response, after a minimum of 2 cycles of the rescue regimen. 3. Patients with DLBCL or grade 3 b Follicular lymphoma or PTCL (including anaplastic ALK +) in first complete or partial response, if more than one treatment line have been required to reach this first complete or partial response. 4. Transformed B cell lymphoma in first CR 5. Patients with PTCL (other than anaplastic ALK +) in first CR * Performance status (ECOG) <0=2. * Adequate renal, hepatic, and bone marrow function (assessed < 14 days before initiation of the study treatment): 1. Neutrophil count <o=1.5 x 109/L 2. Platelet count <o=100 x 109/L 3. Haemoglobin <o=8.0 g/dL 4. Creatinine serum >o=1,5 x ULN mg/dl 5. Serum bilirubin <o=1.5 x ULN and alkaline phosphatase <o=2.5 x ULN 6. AST, ALT <o=2.5 x ULN (<o=5 x ULN in case of liver metastasis). * Adequate pulmonary function: forced expiratory volume at 1 second > 65% of predicted or a diffusing capacity of the lung for CO >o=50%. * Cardiac ejection fraction or greater than 50% by echocardiogram or FEVI. * A woman capable of gestation (see definition below) should: * Have two medically supervised negative pregnancy test (minimum sensitivity of 25 mIU / ml) before starting study therapy (the first pregnancy test should be completed in 10 to 14 days prior to initiating bendamustine and the latter pregnancy test 24 hours before the start of this drug). * Commit to a continued abstinence of heterosexual relationship or agree to use reliable contraception without interruption, 28 days before starting the study therapy, during the study therapy and for 28 days after stopping therapy study. A woman capable of gestation is defined as sexually mature woman who: * has not undergone hysterectomy or bilateral oophorectomy and * is not naturally postmenopausal (amenorrhea as a result of cancer treatment does not rule the reproductive potential) for at least 24 consecutive months (i.e., menses at any time during the previous 24 consecutive months). Exclusion Criteria: * Impossibility of collecting, via apheresis, a number of CD34+ cells >o=2 x 106/kg * To receive any of the following treatments in the 28 days before the start the study treatment: i.chemotherapeutic or antitumor agents ii.radiation therapy, except in limited fields, to a maximum dose of <o=10 Gy to control serious life-threatening symptoms iii.glucocorticoids, except doses equivalent to <o=1 mg / kg of prednisolone / day with a duration <o=7 days iv.any therapeutic agent under investigation. * Known involvement of the central nervous system (CNS) by lymphoma * Abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure NYHA class III or IV, uncontrolled hypertension or a history of antihypertensive treatment poor compliance, uncontrolled arrhythmias with treatment, except extrasystoles or minor conduction disorders. * Other serious or uncontrolled medical condition, such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease. * Known or suspected hypersensitivity to any of the agents or excipients of the regime under evaluation. * Presence of any limitations that compromise the patient's ability to comply with the study treatment. * Positive serology for HIV, HCV or HBV surface antigen (HBsAg). If the HBsAg is negative but anti-core antibodies (HBcAb) are positive and antibody against surface antigen (HBsAb) are negative, there will be a HBV DNA test; If positive results the patient may not be included in the trial. If both types of antibodies HBcAb and HBsAb are positive (indicative of past infection), the patient may be included in the study. * Previous history of malignancies other than lymphoma (except basal cell or squamous cell skin carcinoma and carcinoma in situ of the cervix or breast) unless the patient is free of disease beyond 5 years. * Major surgery procedure within 30 days prior to entering this study. * Pregnant or nursing females.

NCT_ID NCT01296256

Study_NameBendamustine, Cytarabine, Etoposide and Melphalan (BeEAM) as Conditioning for Autologous Stem Cell Transplant (ASCT) in Aggressive Non Hodgkin's Lymphoma (NHL).

Study Objectives The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with locally advancing or metastatic melanoma. Conditions: Metastatic Melanoma Intervention / Treatment: DRUG: Bevacizumab (Avastin), DRUG: dacarbazine, DRUG: interferon-alfa-2a (Roferon-A) Location: Finland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * histologically confirmed malignant melanoma either locally progressing inoperable or metastatic * measurable/evaluable disease in accordance with RECIST criteria * WHO performance status 0 <= age <= 2 * normal organ function * signed written informed consent Exclusion Criteria: * unevaluable disease * major surgery within 28 days prior to day 0 * uncompleted radiotherapy * CNS metastases * serious non-healing wound or ulcer * bleeding diathesis or coagulopathy * uncontrolled hypertension * clinically significant cardiovascular disease * depression or psychosis, which needs medication * ongoing treatment with aspirin (>325 mg/day) * pregnancy * any other serious or uncontrolled illness * previous chemotherapy for metastatic melanoma

NCT_ID NCT00308607

Study_NameBevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

Study Objectives The purpose of this study is to find out what effects (both good and bad) two medications (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is "dose escalating" meaning that patients will receive different doses of medication depending on when they enter the study. Participation in the study will last approximately 3 months and will include an initial screening visit, a visit once each week for 3 weeks to receive the study medications, and then 2 additional visits around the time of your surgery to remove your lung cancer tumor. Conditions: Non Small Cell Lung Cancer Intervention / Treatment: DRUG: Velcade and Vorinostat Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Histologically confirmed NSCLC (clinical stage IB, IIA, IIB, IIIA, or selected IIIB (T4N0 <= age <= 1M0)), exclusive of patients with MPE * Planned surgical resection * Age > 18 years * ECOG performance status 0 <= age <= 1 * Patient has adequate organ and marrow function, as defined below: * Patient has a platelet count of > 100 x 109/L * Patient has a WBC count of > 3.5 x 109/L * Patient has an absolute neutrophil count of > 1.5 x 109/L * Patient has hemoglobin of > 8 gm/dl. Patients may receive transfusions, erythropoietin or darbepoetin to achieve this hemoglobin level. * Patient has a serum creatinine of < 2.0 mg/dL * Patient has AST < 1.5 x ULN * Patient has bilirubin < 1.5 x ULN * Patient has INR < 1.5 x ULN * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. * Male subject agrees to use an acceptable method for contraception for the duration of the study Exclusion Criteria * Previous chemotherapy or radiation therapy within 5 years before enrollment. * Prior history of treatment for a known NSCLC within the last 5 years of if > 5 years but still thought by the investigator to represent recurrent disease. * Prior exposure to either Velcade or Vorinostat * Prior exposure to any HDAC inhibitors within the previous 30 days. Patients who have received such agents for other indications may enroll after 30-day wash-out period. Subject may not take any other HDAC inhibitor during this trial. * Patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment. * Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. * Patient has hypersensitivity to VELCADE, boron or mannitol. * Patient has known allergy to any component of Vorinostat (MK-0683) * Female subject is pregnant or breast-feeding. Confirm by a negative serum B-hCG pregnancy test result obtained during screening (not required for post-menopausal or surgically sterilized women). * Patient is participating or has participated in another investigational trial, and has received other investigational drugs/therapies within 30 days of enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Patient has history of GI surgery or other procedures that might, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs. * Subject is currently taking herbal remedy and/or homeopathic agent which cannot (or the patient is unwilling) be discontinued during the conduct of this trial.

NCT_ID NCT00731952

Study_NamePhase I Study of Induction Therapy With VELCADE and Vorinostat in Patients With Surgically Resectable Non-Small Cell Lung Cancer

Study Objectives This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with operable Stage III HER2 non-overexpressing breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: Eribulin Location: France, Germany, Spain, Portugal Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Written informed consent, specifically highlighting the molecular characterization of tumor and genomic samples * Age >=18 years * Histologically confirmed invasive breast carcinoma, with all of the following characteristics: * Primary tumor >=2cm in largest diameter (cT1 <= age <= 3) * cN0 <= age <= 1 * No evidence of distant metastasis (M0) * Breast cancer (BC) eligible for primary surgery * Available pre-treatment core (Tru-cut) biopsy or possibility of performing one * HER2-negative BC (as per local assessment), defined as either of the following: * 0 <= age <= 1+ expression by IHC * 2+ expression by IHC and in situ hybridization (FISH/CISH) without HER2 gene amplification (<4 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to Cr17 signals] of <1.8) * Is situ hybridization (FISH/CISH) without HER2 gene amplification, independently of IHC * Known hormone receptor (ER/PgR) status (as per local assessment) or the possibility of performing the tests * Known percentage of hormone receptor (ER/PgR) and Ki67-positive tumor cells (as per local assessment), or possibility of performing the tests * In the case of a multifocal tumor, the largest lesion must be >=2 cm and designated the "target" lesion for all subsequent tumor evaluations and HER2-negative status must be documented in all the tumor foci * ECOG performance status of 0 or 1 * Laboratory values as follows: * Absolute neutrophil count (ANC) >=1.5 x 109/L * Platelets count >=100 x 109/L * Hemoglobin >=9 g/dL * Serum bilirubin <=1.5 time the upper limit of normal (ULN) * Alanine aminotransferase and aspartate aminotransferase (AST) <=2.5 x ULN * Alkaline phosphatase <=2.5 x ULN * Serum creatinine <=1.5 mg/dL or calculated creatinine clearance >=60 mL/m * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol * Availability of genomic DNA (via whole blood) Exclusion Criteria: * Any prior treatment for primary invasive BC * Metastatic, locally advanced or inflammatory (i.e., Stage III-IV) BC * Bilateral invasive BC * Multicentric BC, defined as the presence of two or more foci of cancer in different quadrants of the same breast * Pre-existing peripheral neuropathy of any grade * Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) * Clinically significant (i.e., active) cardiovascular disease * Long QT syndrome * Concomitant use of inhibitors of hepatic transport proteins such as organic anion-transporting proteins, P-glycoprotein, multidrug resistant proteins etc * Major medical conditions that might affect study participation (e.g., uncontrolled seizure disorder, uncontrolled pulmonary, renal or hepatic dysfunction, or uncontrolled infection) * Other primary malignant tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix * Known human immunodeficiency virus(HIV) infection or other active or serious infection requiring IV antibiotics at randomization * Pregnancy or breastfeeding women * Women of childbearing potential(<2 years after the last menstruation) not using effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug * Administration of any live virus vaccine within 8 weeks preceding study entry * Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study * Requirement for radiation therapy concurrent with study anticancer treatment * Known hypersensitivity to any of the study drugs or excipients * Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee

NCT_ID NCT01669252

Study_NamePharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer

Study Objectives To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer Conditions: Prostatic Neoplasms Intervention / Treatment: DRUG: ASP3550 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages * Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included * Has a serum testosterone level above 1.5 ng/mL at screening * Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2 Exclusion Criteria: * Previous or present endocrine treatment for prostate cancer. However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding Screening Visit may be included * Is being treated with a 5α-reductase inhibitor * Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months * Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema

NCT_ID NCT00568516

Study_NamePhase II Study of ASP3550 in Patients With Prostate Cancer

Study Objectives The goal of this clinical research study is to find out how well the drug Zolinza (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell Non-Hodgkin's Lymphoma (NHL). The safety of these drugs in combination and the best dose of vorinostat when given in combination with CHOP will also be studied. Conditions: Lymphoma Intervention / Treatment: DRUG: Zolinza (vorinostat), DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisone Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have a new diagnosis of T-cell NHL eligible histologies include:Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma (ALK) (ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, intestinal T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma. * Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk. A minimum of four cycles of therapy will be given before evaluation for to hematopoetic stem cell transplant. * Patients must have biopsy proven disease which can include bone marrow and/or lymph node (cutaneous only disease is excluded) * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Patients must be age 18 years and above.There is no dosing or adverse event data are currently available on the use of vorinostat in patients <18 years, children are excluded from this study but may be eligible for future pediatric phase 2 combination trials. * There is Patients are required to have adequate bone marrow reserve as indicated: Absolute neutrophil count (ANC) >= 1000/mm^3, Platelets >= 50,000/mm3, Hemoglobin >= 8g/dL. If there is bone marrow involvement by lymphoma then there is no minimum level of counts required. * Patients must have adequate liver function as indicated by: Bilirubin <= 1.5 times the upper limit of normal (ULN), Alanine transaminase (ALT) <=2 times the (ULN) or aspartate transaminase (AST) <= 2 times the ULN. These values must be obtained within two weeks before protocol entry. * Patients are required to have adequate renal function as indicated by a serum creatinine <= 2.5 mg/dL. This value must be obtained within two weeks before protocol entry. * Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >= 50%. * Concomitant steroids may continue provided they are being used for symptom management and not for treatment of lymphoma. * Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study * Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized). * Female patients of childbearing potential must have a negative serum pregnancy test (Beta human chorionic gonadotropin (hCG)) within 72 hours of receiving the first dose of vorinostat. * Patients must have the ability able to give informed consent. Exclusion Criteria: * 1. Patients with a) T-cell lymphoma with skin involvement only are excluded if they have no evidence of systemic disease b)T-cell prolymphocytic leukemia (T-PLL) c) T-cell large granular lymphocytic leukemia d) Primary cutaneous CD30+ disorders: anaplastic large cell lymphoma and lymphomatoid papulosis e) Angiocentric/nasal type T/Natural Killer (NK)-cell lymphoma f) Hepatosplenic gamma-delta T-cell lymphoma * Patients with active Hepatitis B and/or Hepatitis C infection. * Patients with known HIV infection are excluded. a) These patients are excluded secondary to potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy. * Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved. * Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes:a) Congestive heart failure, b) Severe CAD, c) Cardiomyopathy, d) Uncontrolled cardiac arrhythmia, e) Unstable angina pectoris, f) Recent MI (within 6 months). * Patients with prior exposure to either vorinostat (including other histone deacetylase (HDAC) inhibitors except valproic acid) or anthracyclines: a) Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment. * Patients who are pregnant or breast-feeding. a)Effects of this treatment on the fetus and young children are unknown at this time. * Patients who have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast who is currently without evidence of disease. * Patients undergoing anti-neoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within the past four weeks. * Patients with deep vein thrombosis within three months. * Patient with concurrent use of complementary or alternative medicines. * Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements. * Patients with grade 2 or more neuropathy. * Patients with known central nervous system (CNS) lymphoma.

NCT_ID NCT00787527

Study_NameSAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma

Study Objectives This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients. Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE. Conditions: Colorectal Cancer Screening Intervention / Treatment: DEVICE: PillCam® COLON 2 procedure-CONTROL, DRUG: Senna tablets, DRUG: PEG, DRUG: Metoclopramide, DRUG: Erythromycin, DRUG: SUPREP oral sulfate solution, DRUG: Bisacodyl, DRUG: SUPREP oral sulfate solution with Gastrografin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subject is between 50 and 75 years. * Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of colorectal cancer (CRC) or adenomas, inflammatory bowel disease, or high-risk genetic syndromes. * Subject is willing and able to participate in the study procedures and to understand and sign the informed consent. Exclusion Criteria: * Subject with history of polyps (including those identified by computed tomography [CT], optical colonoscopy, sigmoidoscopy, etc.). * Subject with history of negative colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) within 5 years as these subjects would be defined not requiring screening in this time frame. * Subject with suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety. * Subject with any condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula. * Subject with dysphagia or any swallowing disorder. * Subject with serious medical conditions that would increase the risk associated with capsule or colonoscopy that are so severe that screening would have no benefit. * Subject with a cardiac pacemaker or other implanted electromedical device. * Subject expected to undergo MRI examination within 7 days after ingestion of the capsule. * Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (BUN), and/or glomerular filtration rate (GFR) outside of the local laboratory reference range. * Subject with known gastrointestinal motility disorders. * Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use. * Subject with comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months. * Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity). * Subject is pregnant, suspected pregnant, or is actively breast-feeding. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years). * Subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.

NCT_ID NCT02481219

Study_NameOptimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

Study Objectives The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML). This study also determined the pharmacokinetic (PK) parameters of gilteritinib. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: Gilteritinib, DRUG: Voriconazole, DRUG: Midazolam, DRUG: Cephalexin Location: Italy, Germany, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subject is defined as morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) and fulfills one of the following: * Refractory to at least 1 cycle of induction chemotherapy * Relapsed after achieving remission with a prior therapy * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status <= 2. * Subject's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents. * Subject must meet the following criteria as indicated on the clinical laboratory tests*: * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x institutional upper limit normal (ULN) * Total serum bilirubin < 1.5x institutional ULN * Serum creatinine < 1.5 x institutional ULN or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation. * Subject agrees not to participate in another interventional study while on treatment. Exclusion Criteria: * Subject was diagnosed as acute promyelocytic leukemia (APL). * Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis). * Subject has active malignant tumors other than AML or Myelodysplastic syndrome (MDS). * Subject has persistent nonhematological toxicities of >= Grade 2 (Common Terminology Criteria for Adverse Events v4), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery). * Subject has had hematopoietic stem cell transplant (HSCT) and meets any of the following: * Is within 2 months of transplant from C1D1 * Has clinically significant graft-versus-host disease requiring treatment * Has >= Grade 2 persistent non-hematological toxicity related to the transplant. Donor lymphocytes infusion (DLI) is not permitted <= 30 days prior to study registration or during the first cycle of treatment on the study in Cohort 1 and first two cycles of the treatment in Cohort 2 * Subject has clinically active central nervous system leukemia * Subject has disseminated intravascular coagulation abnormality (DIC) * Subject has had major surgery within 4 weeks prior to the first study dose. * Subject has had radiation therapy within 4 weeks prior to the first study dose * Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is >= 45% * Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of Cytochrome P450-isozyme3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject * Subject required treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject. * Subject has an active uncontrolled infection * Subject is known to have human immunodeficiency virus infection * Subject has active hepatitis B or C, or other active hepatic disorder

NCT_ID NCT02014558

Study_NameDose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Study Objectives The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/ bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Folfox plus Bevacizumab and reolysin, DRUG: Folfox plus Bevacizumab Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must have a histological diagnosis of colorectal adenocarcinoma. * All patients must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) available for translational studies and must have provided informed consent for the release of the block. * Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative). All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows: Chest X-ray >= 20 mm CT/MRI scan (with slice thickness of < 5 mm) >= 10 mm longest diameter Physical exam (using calipers) >= 10 mm Lymph nodes by CT scan >= 15 mm measured in short axis * Patients must have advanced and or metastatic disease, for which no curative therapy exists and for which systemic therapy is indicated. * ECOG performance of 0, 1 or 2. * Age >= 18 years. * Previous Therapy Surgery: Previous major surgery is permitted provided that it has been at least 21days prior to patient randomization and that wound healing has occurred. Chemotherapy: Patients may NOT have received any prior cytotoxic chemotherapy for advanced or metastatic disease. Prior adjuvant fluoropyrimidine-based therapy is permitted provided completed at least one year prior to enrollment and the regimen did not include oxaliplatin or bevacizumab. Exceptions may be made for low dose chemotherapy given as a radiosensitizing agent. Other Therapy: Patients may have received other therapies including immunotherapy, or with signal transduction inhibitors, providing that the patient has recovered from all reversible drug related toxicity (with the exception of alopecia) and adequate washout period has been met. Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial. Exceptions may be made for low dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG. * Laboratory Requirements (must be done within 7 days prior to randomization) Hematology: Granulocytes (AGC) >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Biochemistry: Serum creatinine <= 1.5 x ULN Total bilirubin <= 1.0 x ULN (unless elevated secondary to conditions such as Gilbert's disease) ALT and AST <= 3 x ULN (Note: <= 5 x ULN if documented liver metastasis) Proteinuria < 2g/24 hrs (screen using spot testing; if >= grade 2 repeat with mid-stream urine - if still >= grade 2 then urine collection for 24 hours to confirm <2g/24hrs) * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested. * Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up. * Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life (EORTC QLQ-C30) in either English or French. The baseline assessment must already have been completed. Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible. The baseline assessment must be completed within 14 days prior to randomization. * In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization. Exclusion Criteria: * Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for >= 3 years. (Please call NCIC CTG if any questions about the interpretation of this criterion). * Patients who are on immunosuppressive therapy or have known HIV infection or active hepatitis B or C. * Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. * Patients with significant cardiac (including uncontrolled hypertension) or pulmonary disease, or active CNS disease or infection. * Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components. * Patients with history of central nervous system metastases or untreated spinal cord compression. * Patients who have had prior treatment with oxaliplatin or bevacizumab, who have contraindications to treatment with 5FU (for e.g. known DPD deficiency or severe cardiac disease), and or neuropathy > grade 1. * Patients who are not sterile unless they use an adequate method of birth control.

NCT_ID NCT01622543

Study_NameReolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer

Study Objectives The purpose of the study is to evaluate the pharmacokinetics and safety from the mixture of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC) delivery (Part 1) and CF (co-formulated daratumumab and rHuPH20 preparation) administration via SC delivery of daratumumab (Part 2) and to evaluate the safety of Dara-CF 1800 milligram (mg) SC delivery without pre-dose and post-dose corticosteroids (Part 3). Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Daratumumab Subcutaneous (SC) Administration, DRUG: Recombinant Human Hyaluronidase [rHuPH20]) SC Administration Location: Sweden, United States, Spain, Netherlands, Denmark, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Participants proven to have multiple myeloma (MM) diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria * Measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level greater than or equal to (>=) 200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgD, or IgE multiple myeloma (serum M-protein level >= 0.5 g/dL or urine M-protein level >= 200 mg/24 hrs); or (c) light chain multiple myeloma (serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Pretreatment clinical laboratory values must meet protocol-defined parameters during the Screening phase * Man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use a barrier method of birth control example (eg), either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the final dose of study drug * Relapsed or refractory disease. Relapse is defined as progression of disease after an initial response to previous treatment, more than 60 days after cessation of treatment. Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment * Prior treatment with less than or equal to (>=) 2 treatment lines of anti-myeloma therapy. Prior lines of therapy must include a proteasome inhibitor (PI) (eg, bortezomib, carfilzomib) and an immunomodulatory drug (IMiD) (example, thalidomide, lenalidomide, pomalidomide) in any order during the course of treatment. Each prior line of therapy may consist of one or more agents and may include induction, hematopoietic stem cell transplantation, and/or maintenance therapy. Radiotherapy, bisphosphonates, or a single short course of steroids is not considered a prior line of therapy Exclusion Criteria: * Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously * Participant has received anti-myeloma treatment within 2 weeks before Cycle 1 Day 1 * Participant has previously received an allogenic stem cell transplant; or participant has received autologous stem cell transplantation (ASCT) within 12 weeks before Cycle 1 Day 1 * Participant has a history of malignancy (other than multiple myeloma) within 5 years before Cycle 1 Day 1 (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence) * Participant is exhibiting clinical signs of meningeal involvement of multiple myeloma

NCT_ID NCT02519452

Study_NameA Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Study Objectives This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors. Conditions: Advanced Solid Malignancies Intervention / Treatment: DRUG: HSP990 Location: France, Canada, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists * All patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression * All patients must have documented progressive disease before entering the study * Age >= 18 years * World Health Organization (WHO) Performance Status <= 2 * Life expectancy of >= 12 weeks * Patients must have the certain laboratory values * Patients able and willing to swallow capsules * Ability to understand the patient information and informed consent form and comply with the protocol * Signed and dated written informed consent is available * Only for patients enrolled at MTD: willing to provide a fresh pre-dose and post-dose tumor biopsy. Exclusion Criteria: * Patients with present or history of CNS metastasis. * Prior treatment with any Hsp90 or HDAC inhibitor compound. * Patients who have not recovered from side effects of previous systemic anticancer therapy to < CTCAE Grade 2 prior to the first dose * Patients identified to be "poor or intermediate CYP2C9 metabolizers" * Patients who received systemic anti-cancer treatment prior to the first dose of HSP990 within the following time frames: * Patients who have received cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C) prior to starting study drug or who have not recovered from the side effects of such therapy * Patients who have received biologic therapy (e.g., antibodies) within a period of time that is <= 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy * Patients who have been treated with a continuous or intermittent small molecule therapeutic within a period of time that is <= 5 t1/2 or <= 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy * Patients who have received any other investigational agents within a period of time that is <= 5 t1/2 or less than the cycle length used for that treatment or <= 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy * Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) <= 4 weeks or limited field radiation for palliation <= 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. * Patients who have undergone major surgery <= 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * Treatment with therapeutic doses of sodium warfarin (Coumadin). * Patients using medications that are CYP2C9 inhibitors and/or medications known to have QT prolongation effect and cannot be switched or discontinued to an alternative drug prior to commencing HSP990 dosing. * Unresolved diarrhea >= CTCAE grade 2 * Patients who do not have either an archival tumor sample available or readily obtainable in the course of the study or are unwilling to have a fresh tumor sample collected at baseline. * Pregnant or lactating women. * Fertile women of childbearing potential (WCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile). Male patients whose partners are WCBP, not using adequate contraception. * Acute or chronic liver disease. * Acute or chronic renal disease. * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of HSP990 * Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol. * Known diagnosis of HIV infection (HIV testing is not mandatory). * Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention * Cardiac exclusion criteria: * History (or family history) of long QT syndrome. * Mean QTcF >= 480 msec on screening ECG * History of clinically manifest ischemic heart disease including myocardial infarction, or unstable angina <= 3 months prior to study start. * Left ventricular (LV) dysfunction (LVEF <= 45%) by MUGA or ECHO * Clinically significant ECG abnormalities including one or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB), or 3rd degree AV block. * History or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes. * Clinically significant resting bradycardia (< 50 beats per minute). * Patients who are currently receiving treatment with any medication which has a relative risk or prolonging the QTcF interval or inducing Torsades de Pointes (as listed in Post-text supplement 2) and cannot be switched or discontinued to an alternative drug prior to commencing HSP990 dosing. * Obligate use of a cardiac pacemaker. * Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) Other protocol-defined inclusion/exclusion criteria may apply

NCT_ID NCT00879905

Study_NameA Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors

Study Objectives This randomized phase III trial is studying gemcitabine and bevacizumab to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Combining gemcitabine with bevacizumab may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without bevacizumab in treating pancreatic cancer. Conditions: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer Intervention / Treatment: DRUG: gemcitabine hydrochloride, BIOLOGICAL: bevacizumab, OTHER: placebo, OTHER: laboratory biomarker analysis, OTHER: pharmacogenomic studies, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Histologic or cytologic documentation of adenocarcinoma of the pancreas; documentation of disease extent by CT scan is required; radiologically measurable disease is not required; patients with documented invasion of adjacent organs (e.g., duodenum, stomach) by CT scan are not eligible * No prior chemotherapy for metastatic disease * If the patient received adjuvant therapy, it must have been completed at least 4 weeks prior to enrollment on this study; the patient must have recovered from all treatment related toxicities and must have evidence of disease progression following adjuvant treatment * Prior radiation therapy, with or without a radiosensitizing dose of fluoropyrimidines, is allowed provided the patient has disease outside of the radiation port; at least 4 weeks must have elapsed from completion of the radiation therapy and all signs of toxicity must have resolved * No prior treatment with gemcitabine or bevacizumab in the adjuvant or metastatic setting * No current or recent (within 1 month) use of a thrombolytic agent * Patients may not have had prior therapy with other VEGF inhibitors * No recent invasive surgical procedures; this includes: * Major surgical procedure (e.g. exploratory laparotomy or laparoscopy), open biopsy, or significant traumatic injury within 28 days prior to registration * Fine needle aspirations or venous access device within 7 days prior to registration * Anticipation of need for major surgical procedures during the course of the study * No clinically significant cardiovascular disease; this includes: * Uncontrolled hypertension (blood pressure > 150/90 on medication) * New York Heart Association grade II or greater congestive heart failure * Serious cardiac arrhythmia requiring medication * No recent (within 6 months) arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are also ineligible * No evidence of CNS disease, including primary brain tumor, or any brain metastasis * No serious or non-healing wound, ulcer or bone fracture * No serious active infection (viral, fungal bacterial); no infection requiring parenteral antibiotics at time of registration * Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies are not eligible * Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered; patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse * Women must be non-pregnant and non-breast feeding * ECOG Performance status of 0, 1 or 2 * Granulocytes >= 1,500/μl * Platelet count >= 100,000/μl * Creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/min * Total bilirubin <= 1 x upper limit of normal * SGOT(AST) <= 2.5 x upper limit of normal * PT INR =< 1.5, unless patient is on full dose warfarin * Urine protein; for >= 1+ proteinuria, 24 hour urine collection must demonstrate < 1 gm of protein/24 hours * Required diagnostic procedures: * CT of the abdomen * Chest x-ray

NCT_ID NCT00088894

Study_NameGemcitabine With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Study Objectives This research will examine the effectiveness of calcitriol in treating bone loss in women who are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women. Conditions: Breast Cancer Intervention / Treatment: DRUG: Calcitriol Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Must be female. * Must have pathologically confirmed incident, primary invasive breast cancer. * Must be awaiting surgical resection. * Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended. * Must provide informed consent. * Must be willing to discontinue use of calcium and/or vitamin D supplements other than multivitamin supplementation. * Participants must have an ionized serum calcium level within normal limits (1.19 <= age <= 1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl. Exclusion Criteria: * Subjects with life-threatening conditions that would preclude them from breast cancer treatment including: chronic cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease. * Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol. * Patients with a previous history of any other cancer except non-melanomous skin cancer within the past 5 years. * Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years. * Patients with hypercalcemia (corrected serum CA > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity. * Patients currently taking calcium supplements or aluminum-based antacids must immediately discontinue their use if they are to enroll in the study. * Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study. * Patients with a known sensitivity to calcitriol. * Women who are pregnant or lactating. * Women on antiresorptive drugs (e.g. bisphosphonates) within the past year. * Women currently using oral contraception. * Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran). * Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.

NCT_ID NCT01293682

Study_NameEffects of High Dose Calcitriol in Breast Cancer Patients

Study Objectives This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes \[T cells\]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work in treating participants with sarcoma that has spread to other places in the body (advanced) or that has come back (recurrent). Modified T cells used in this study are taken from participants, are changed in a laboratory, and may "kill" some types of tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide may help the body get ready to receive the modified T cells. Interleukins, such as aldesleukin, are proteins made by white blood cells and other cells in the body and may help regulate immune response. LV305 and CMB305 may help stimulate the immune system. Giving modified T cells, chemotherapy, aldesleukin, LV305, and CMB305 may work better in treating participants with sarcoma. Conditions: HLA-A*0201 Positive Cells Present, NY-ESO-1 Positive Tumor Cells Present, Recurrent Myxoid Liposarcoma, Recurrent Synovial Sarcoma Intervention / Treatment: BIOLOGICAL: Aldesleukin, BIOLOGICAL: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, DRUG: Cyclophosphamide, BIOLOGICAL: Dendritic Cell-targeting Lentiviral Vector ID-LV305 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histopathologic documentation of synovial sarcoma or myxoid liposarcoma with the diagnosis of advanced or recurrent disease who have received prior standard chemotherapy. Patients with other sarcoma subtypes if proven to be NY-ESO-1 positive and meeting all other eligibility criteria listed below will also be included. * Tumor expression of NY-ESO-1 (2+ staining or > 25%) by immunohistochemistry (IHC). * Expression of HLA-A*0201. * Eastern Cooperative Oncology Group (ECOG)/ Zubrod performance status of '0 <= age <= 1' * Life expectancy > 6 months. * Electrocardiography (ECG) without evidence of clinically significant arrhythmia or ischemia. * Women of childbearing potential (WOCBP) must be using at least one highly effective or two effective accepted methods of contraception to avoid conception throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion and/or at least 3 months after the study agents LV305 or CMB305 are stopped. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. * Men must be willing and able to use an acceptable method of birth control such as latex condom during the dosing period and for at least 3 months after completion of the study agent administration (T cell infusion and/or LV305 or CMB305) if their sexual partners are WOCBP. * Willing and able to give informed consent. * (Prior to treatment) Note: evaluate at least 1 week before T cell infusion. a. Adequate venous access - consider peripherally inserted central catheter (PICC) or central line. b. ECOG/Zubrod performance status of '0 <= age <= 1. c. Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography [CT scan]). d. At least 4 weeks must have elapsed since the last chemotherapy, immunotherapy, radiotherapy or major surgery. At least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. e. Toxicity related to prior therapy must either have returned to =< grade 1, baseline, or been deemed irreversible. f. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 3 months after study drug is stopped. g. Willing and able to give informed consent. Exclusion Criteria: * Patients with active infections or oral temperature > 38.2 Celsius (C) within 72 hours of leukapheresis. The procedure may be deferred. * Investigational therapy within 3 weeks. * Prior administration of other NY-ESO-1 targeting immunotherapeutics. * Significant immunosuppression from concurrent, recent (=< 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti-inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy. * Cancer therapies, including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) within 3 weeks prior. * Psychiatric, other medical illness or other condition that in the opinion of the principal investigator (PI) prevents compliance with study procedures or ability to provide valid informed consent. * Significant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy. * Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) grade III or IV heart failure. * Peripheral blood leukocyte count (white blood cells [WBC]) < 3000/mm^3. * Absolute neutrophil count =< 1500/mm^3. * Platelets < 75000/mm^3. * Hemoglobin < 10 gm/dL. * Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN). * Total serum bilirubin > 1.5 x ULN (patients with Gilbert's disease may be included if their total bilirubin is =< 3.0 mg/dL). * Creatinine > 1.5 x ULN. If higher check 24hr clearance, if < 50 ml/min then patient will be excluded. * INR (prothrombin time ratio) or partial thromboplastin time (PTT) > 1.5 x ULN (Please note: patients with hematopoietic cell transplantation (Hct) < 30%, WBC < 2500/mm/^3 and platelets < 50,000/mm^3 immediately prior to leukapheresis. The procedure may be deferred.) * History of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ). * Positive screening tests for human immunodeficiency virus (HIV), hepatitis (Hep) B, Hep C, active tuberculosis or recent (< 2 week ago) clinically significant infection or evidence of active HIV, Hep B, or Hep C. (Note: If positive results are not indicative of true active or chronic infection, the patient can be treated.) * Brain metastases considered unstable as: a. without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR b. associated with symptoms and/or findings; OR c. requiring corticosteroids or anticonvulsants in the prior 60 days. * Pregnant, planning to become pregnant, or breast feeding. * Known allergy(ies) to any component of CMB305 or LV305. * Men or women of reproductive ability who are unwilling to use effective contraception and women of childbearing potential who are unwilling to undergo pregnancy testing before and during the study. * Clinically significant pulmonary dysfunction, as determined by medical history and physical exam. Patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in 1 second (FEV1) < 2.0 L or carbon monoxide diffusing capability (DLco) (correlation for hemoglobin [corr for Hgb]) < 75% will be excluded. * Significant cardiovascular abnormalities as defined by any one of the following: a. congestive heart failure, b. clinically significant hypotension, c. symptoms of coronary artery disease, d. presence of cardiac arrhythmias on electrocardiography (EKG) requiring drug therapy, e. ejection fraction < 50 % (dobutimine stress echo). * Active and untreated central nervous system (CNS) metastasis. * Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable. * Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy. * No prisoners or children will be enrolled on this study.

NCT_ID NCT03450122

Study_NameModified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma

Study Objectives The purpose of this study is to evaluate the response rate of Paclitaxel combination chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer. Conditions: Gastric Cancer Intervention / Treatment: DRUG: Taxol, UFT,Leucovorin Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * At least 18 years * Patients with histologically confirmed gastric adenocarcinoma, defined as locally advanced unresectable or metastatic or recurrent disease * Patients with at least one measurable lesion * ECOG performance status of 0,1 or 2 * Patients with no prior chemotherapy and radiotherapy for metastatic disease (patients who have received and completed prior adjuvant chemotherapy at least 6 months prior to study enrollment may be enrolled into the study, prior taxane chemotherapy should be excluded) * Patients with physiological functions (bone marrow, heart, liver, kidney, etc.) meeting the following criteria: WBC >4000/mm3, ANC >1500/mm3, PLT >100,000/mm3, Hb >9.0g/dL, ALT<3 times the ULN (<5 times the ULN for liver metastasis cases), Total bilirubin <1.5mg/dL, Creatinine <the upper limit of normal * Accessible for treatment and follow-up * Give written informed consent * Women of child bearing potential must have a negative plasma or urine pregnancy test within 72 hours prior to start of the study medication Exclusion Criteria: * Patients who received surgery within 14 days prior to enrollment * Patients with CNS metastasis * History of hypersensitivity related to the administration of polyoxyethylated-castor-oil (cremophor EL)-containing preparation (e.g. cyclosporin,etc.) or hardened-castor-oil-containing preparation (e.g. vitamin preparation for injection,etc.) * Patients with a history of severe hypersensitivity * Active infectious symptoms * Patients with active gastrointestinal bleeding, intestinal obstruction or other situation that dose not allow oral intake of medication * Patients with ascites that adversely affects performance status * Pre-existing CTC Grade 2 or greater neuropathy (motor or sensory) * Pregnant or nursing females * Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug

NCT_ID NCT00154778

Study_NameTaxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer

Study Objectives This clinical trial studies steady state blood volume maps using ferumoxytol non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor cells and the blood vessels in and around the tumors. Conditions: Glioblastoma Intervention / Treatment: PROCEDURE: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, DRUG: Ferumoxytol, DRUG: Gadoteridol, PROCEDURE: Magnetic Resonance Imaging Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * Subjects must have a known or presumed radiological diagnosis of glioblastoma (GBM); for presumed diagnosis of GBM, histological confirmation of GBM must be completed within 12 weeks of enrollment; (subjects will be removed from study and non-evaluable if no histologic diagnosis of GBM is confirmed) * Subjects must be enrolled before starting chemoradiation, either pre -or post-surgery * All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines * Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal > 6 months or abstinence) for at least two months after each cycle of the study; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Exclusion Criteria: * Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible * Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations; subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion * Subjects who are pregnant or lactating or who suspect they might be pregnant * Subjects who have a contraindication for 3 tesla (T) MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material * Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study * Subject who have received ferumoxytol within 3 weeks of study entry * Subjects with three or more drug allergies from separate drug classes

NCT_ID NCT02359097

Study_NameSteady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma

Study Objectives The purpose of this study is to develop a new drug treatment to reverse tumor resistance to radioiodine in BRAF mutant tumors so that radioiodine can be given to shrink tumors. This study is also being done to find out the highest doses of copanlisib and vemurafenib that, when given in combination, do not cause serious side effects, and whether the study treatment will make radioiodine therapy work better in patients with BRAF-mutant thyroid cancers. Conditions: Thyroid Carcinoma, Thyroid Cancer, Thyroid Cancer, Follicular, Thyroid Cancer (Follicular Cell), Thyroid Cancer, Papillary, BRAF V600E Mutation Positive Intervention / Treatment: DIAGNOSTIC_TEST: I-124 PET/CT lesion dosimetry, DRUG: Vemurafenib, DRUG: Copanlisib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, and poorly differentiated subtypes and their respective variants). * A tumor sample (primary, recurrent, or metastatic tumors) possessing a BRAF V600 mutation, as confirmed in a CLIA-certified laboratory or using an FDA-approved assay * Measurable disease by RECIST v1.1 (tumors in previously irradiated fields may be considered measurable if there is evidence of tumor progression after radiation treatment) * RAIR disease, as defined by any one of the following: * A metastatic lesion that is not RAI-avid on a diagnostic radioiodine scan * An RAI-avid lesion that remained stable in size or progressed despite RAI treatment before entry in this study (there are no size limitations for the index lesion used to satisfy this entry criterion) * The presence of at least 1 FDG-avid lesion * No receipt of treatment for thyroid cancer, defined as: * No I-131 therapy < 6 months before initiation of the protocol (time of initiation of the protocol is defined as the first day of drug therapy with vemurafenib and copanlisib); diagnostic activities of I-131 (0 <= age <= 10m Ci) are allowed within 6months of initiating the protocol * No external beam radiation therapy <4 weeks before initiation of the protocol * No chemotherapy or targeted therapy including TKIs <4 weeks (or <5 half lives of the drug) before the initiation of this protocol * Age of >= 18 years * ECOG performance status <= 2 or Karnofsky Performance Score (KPS) >= 70% * Tissue from the primary tumor or metastases available for correlative studies. Either a paraffin block or at least 20 unstained slides are acceptable (30 unstained slides is ideal); if <20 unstained slides are available, and a paraffin block is not available, the patient may be able to participate at the discretion of the investigator * Able to swallow and retain an orally administered pill without any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels * Agree to undergo 2 research biopsies of (a) malignant lesion(s). Tumor tissue obtained before study consent or treatment can also be submitted in lieu of performance of the first pretreatment biopsy if the Principal Investigator deems it to be of sufficient quantity/quality/timeliness (tumor tissue obtained more than 3 years from time of study consent would not be eligible). Patients may be exempt from biopsy if (1) the investigator or person performing the biopsy judges that no tumor is accessible for biopsy, (2) the investigator or person performing the biopsy feels that the biopsy poses too great of a risk to the patient, or (3) the patient's platelet count is <100,000/mcL or the patient cannot be safely removed from anticoagulation therapy (if the anticoagulation therapy needs to be temporarily held for the biopsy procedure). If the investigator deems a second research biopsy to be high risk, the patient may be exempt from the second biopsy. * Screening laboratory values meeting the following criteria: * WBC >= 2000/µL * Neutrophils >= 1500/µL * Platelets >= 100 × 10^3/µL * Hemoglobin >9.0 g/dL * Lipase <= 1.5 × ULN * AST/ALT <= 3 × ULN * Total bilirubin <= 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin <3.0 mg/dL) * Serum creatinine <= 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = (140 - age in years) x weight in kg x 0.85 / 82 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL Exclusion Criteria: * Untreated metastatic brain or leptomeningeal tumors (metastatic brain or leptomeningeal tumors treated with radiation and/or surgery are allowed) * Prior malignancy if diagnosed and treated within 2 years of trial drug initiation (with the exception of nonmelanoma skin cancers or Stage I cancers treated with curative intent).Patients may be included if they have completed therapy for a prior malignancy >2 years before drug initiation and currently have no evidence of disease * Inability to follow a low-iodine diet or requiring a medication with a high content of iodide (amiodarone) * Current congestive heart failure class >2, as defined by the New York Heart Association functional classification system * Myocardial infarction < 6 months before the initiation of protocol * Unstable angina (angina symptoms at rest) or new-onset angina (begun within the last 3 months) * Uncontrolled hypertension (blood pressure >150/90, despite optimal medical management) * Uncontrolled type I or II diabetes mellitus, as judged by the investigator, or Hgb A1C of >8.5 * Arterial or venous thrombotic event or embolic event, such as a cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within 3 months before the start of study medication * Nonhealing wound, ulcer, or bone fracture (tumor-related nonhealing wounds are allowed) * Active, clinically serious infections CTCAE v5.0 grade >2 * History of concurrent condition of interstitial lung disease and/or severely impaired lung function * Known history of HIV infection (all patients must be screened for HIV up to 28 days before start of study) * Seizure disorder requiring medication * Therapy with a prohibited concomitant medication that cannot be temporarily held (at least 2 weeks before initiation of vemurafenib plus copanlisib until 1 week after the last dose) or replaced with a nonprohibited concomitant medication * Systemic corticosteroid therapy at a daily dose >15 mg prednisone or equivalent (previous corticosteroid therapy must be stopped or reduced to the allowed dose at least 7 days before study registration) * Cytomegalovirus (CMV) PCR-positive at baseline * Evidence or history of a bleeding diathesis or any hemorrhage or bleeding CTCAE v5.0 grade >= 3 within 4 weeks before the start of study protocol * HBV or HCV infection. All patients must be screened for HBV and HCV up to 28 days before the start of study medication using the routine hepatitis virus laboratorial panel. Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA (these patients should receive prophylactic HBV antiviral therapy). Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA * Known hypersensitivity to any of the test drugs, test drug classes, or excipients in the formulation * Substance abuse or medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Patients who are pregnant * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 6 months after the last administration of study treatment. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In cases of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone-level assessment (FSH level in the postmenopausal range) is this acceptable * Male sterilization (at least 6 months before screening). The vasectomized male partner should be the sole partner for that patient * Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system or other forms of hormonal contraception that have comparable efficacy (failure rate <1%)-for example, hormone vaginal ring or transdermal hormone contraception. Note: In cases of use of oral contraception, women should have been stable, on the same pill for a minimum of 3 months before taking study treatment * Women are considered postmenopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks ago. In cases of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone-level assessment is she considered not of child-bearing potential. * Sexually active men, unless they use a condom during intercourse while on treatment and for 6 months after stopping treatment with study drugs (men should not father a child in this period). A condom is required to be used by vasectomized men as well during intercourse to prevent delivery of the drug via semen.

NCT_ID NCT04462471

Study_NameVemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers

Study Objectives This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy. Conditions: Myelodysplastic Syndrome (MDS) Intervention / Treatment: DRUG: lintuzumab, DRUG: lenalidomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Disease confirmation of MDS. * Between 5% and 30% blasts in the bone marrow. * Received treatment for cytopenias within 2-months * ECOG <= 2. Exclusion Criteria: * Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®). * Received chemotherapy/radiotherapy within 4 weeks of study registration. * Received prior bone marrow transplant. * 5q- chromosomal deletion in malignant cells.

NCT_ID NCT00502112

Study_NameA Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)

Study Objectives Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer. Conditions: Carcinoma, Non Small Cell Lung Intervention / Treatment: DRUG: Sagopilone (BAY86-5302, ZK 219477), DRUG: Sagopilone (BAY86-5302, ZK 219477), DRUG: Sagopilone (BAY86-5302, ZK 219477) Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Non-small-cell lung cancer * Only one previous chemotherapy with a platinum-containing drug * Use of highly effective birth control methods in females of child-bearing potential Exclusion Criteria: * No more than 1 previous chemotherapy for advanced disease * Previous participation in another trial within the last 4 weeks * Breast feeding * Active infections

NCT_ID NCT00160069

Study_NameSafety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer

Study Objectives This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis. Conditions: Secondary Progressive Multiple Sclerosis (SPMS) Intervention / Treatment: DRUG: Mayzent Location: Japan Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis Exclusion Criteria: *

NCT_ID NCT04593927

Study_NameLong Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

Study Objectives Anaesthesia and surgical stress during craniotomy can lead to brain damage and activation of inflammatory response. Consequently inflammatory cytokines (IL6, IL8, IL10) are released. Cell mediated immune balance can increase postoperative complications (infections, wound healing, multiple organ dysfunction). Many studies have shown that volatile anaesthetics reduce systemic and local inflammatory response during major surgery, but animal studies have shown that volatile anaesthetics can induce neuroinflammation (IL6, NF-κB) that leads to decline of cognitive function in rodent and possible human. Our aim was to investigate how anaesthetic technique for craniotomy influences the release of inflammatory cytokines. Our hypothesis was that when optimal neuroprotective strategies are followed during surgery intravenous anaesthesia attenuates inflammatory response comparing to inhalational anaesthesia. The investigators included 40 patients anaesthetised with remifentanil based anaesthesia with sevoflurane (S group) or propofol (P group). Plasma levels of IL6, IL8, IL10 were measured during preoperative, perioperative and postoperative periods of both groups of patients. The investigators also noted emergence parameters, postoperative (pain, shivering, vomiting) and neurological complications after surgery. Conditions: Inflammation Intervention / Treatment: DRUG: Propofol, DRUG: Sevoflurane Location: Slovenia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * age 18 <= age <= 80 years * American Society of Anaesthesiologists (ASA) physical status I-III * Scheduled for brain tumour surgery * Glasgow Coma Score 15 * Cooperative Exclusion Criteria: * No written informed consent * Eendocrine systematic disease * Ddrugs that alter endocrine metabolism * History of drug hypersensitivity * Drug addiction * Perioperative blood derivatives.

NCT_ID NCT02229201

Study_NameComparison of Two Anaesthetics on Brain During Brain Tumour Surgery

Study Objectives This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment. Conditions: Breast Cancer, Metastatic Bone Disease Intervention / Treatment: DRUG: ZA, DRUG: Odanacatib, DRUG: Odanacatib matching placebo, DRUG: ZA matching placebo Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Patient has histologically or cytologically-confirmed breast cancer * Patient has documented skeletal metastases Exclusion Criteria: * Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study

NCT_ID NCT00399802

Study_NameA Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)

Study Objectives Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of AP23573 in patients with refractory or recurrent malignancies, including myeloma and lymphoma. Conditions: Tumors, Lymphoma, Multiple Myeloma Intervention / Treatment: DRUG: ridaforolimus Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: (Patients must meet each of the following criteria to be eligible for participation in the study). * Male or female patients, >= 18 years. * Patients with a documented measurable or evaluable malignancy, including myeloma or lymphoma, that is recurrent, advanced, or metastatic. * Patients with disease that is currently refractory to, or not amenable to, standard therapy. * Patients with disease that is currently not amenable to surgical intervention. * Patients with Karnofsky performance status of >= 70% (ECOG performance status of 0 or 1) and an anticipated life expectancy of >= 3 months. * Patients either not of childbearing potential, or agreeing to use a medically effective method of contraception. * Patients with the ability to understand and give written informed consent. Exclusion Criteria: (Patients meeting any of the following criteria are ineligible for participation in the study) * Women who are pregnant or lactating. * Patients with primary CNS malignancies. Patients with leukemia, any form. * Patients with certain hematologic abnormalities. * Patients with certain serum chemistry abnormalities at baseline. * Patients with known or suspected hypersensitivity to either drugs formulated with polysorbate 80 (Tween 80) or any other excipient contained in the test drug formulation. * Patients with known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin). * Patients with significant cardiovascular disease. * Patients with active CNS metastases (or leptomeningeal disease) not controlled by prior surgery or radiotherapy. Note: Patients with treated brain metastases will be eligible if they are on a stable dose of corticosteroids or are without change in brain disease status for at least 4 weeks following related therapy (e.g., whole brain radiation, surgery). * Patients with known HIV infection. * Patients with any active infection. * Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 2 weeks prior to study entry. Note: Patients having undergone recent placement of a central venous access port will be considered eligible for enrollment if they have recovered. * Patients who have any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the test drug. * Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies. * Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements. Drugs and Other Treatments to be Excluded (Either during or within 4 weeks prior to study entry, unless otherwise noted) * Chemotherapeutic agents (standard or experimental). * Other antineoplastic agents. * Immunotherapy (including vaccines) or biological response modifier therapy. * Systemic hormonal therapy. * Herbal preparations or related OTC preparations containing herbal ingredients (e.g., St John's Wort) during or within 2 weeks prior to study entry. * Any prior therapy with rapamycin, CCI-779, or any other rapamycin analog. * Any other experimental therapy during the course of the study. * Radiotherapy for the primary malignancy or metastases.

NCT_ID NCT00060645

Study_NameSafety Study of AP23573 in Patients With Advanced, Refractory or Recurrent Malignancies (8669-013)(COMPLETED)

Study Objectives The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1) Group A - Imatinib failure only (arms 2, 3 and 4) * imatinib-resistant or intolerant CML - Chronic Phase (CP) * imatinib-resistant or intolerant CML - Accelerated Phase (AP) * imatinib-resistant or intolerant CML - Blast Crisis (BC) Group B - Imatinib and other TKI failure (arms 2, 3 and 4) * imatinib-resistant or intolerant CML - Chronic Phase (CP) * imatinib-resistant or intolerant CML - Accelerated Phase (AP) * imatinib-resistant or intolerant CML - Blast Crisis (BC) Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5) Systemic mastocytosis (Sm) (arm 6) Conditions: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive), Hypereosinophilic Syndrome, Systemic Mastocytosis Intervention / Treatment: DRUG: Nilotinib Location: Poland, United Kingdom, Australia, Austria, Denmark, Norway, France, Korea, Republic of, Singapore, Netherlands, Canada, New Zealand, Germany, Sweden, Spain, Italy, Taiwan, Switzerland, Hong Kong, United States, Belgium, Finland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: Main inclusion criteria include: * Patients with CML in blast crisis, CML in accelerated phase defined as never in blast crisis phase, or CML in chronic phase defined as never been in blast crisis phase or accelerated phase who have: *developed progressive disease during therapy with at least 600 mg of imatinib per day, -OR- *patients with CML on imatinib therapy, at any dose, developing progressive disease and the presence of a genetic mutation likely to result in imatinib resistance -OR- *have developed an intolerance to imatinib * Relapsed or refractory Ph+ ALL * Hypereosinophilic syndrome/chronic eosinophilic leukemia. * Systemic mastocytosis who have a clinical indication for treatment. * Prior imatinib therapy for patients with Ph+ ALL, HES/CEL and SM is permitted but is not required * CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib-resistance or intolerance are eligible * Written informed consent prior to any study procedures being performed Exclusion Criteria: * Impaired cardiac function * Patients with severe/chronic or uncontrolled medical conditions (including but not limited to diabetes, infections, GI impairment, CNS infiltration, liver and kidney disease) * Prior and concomitant use of certain medications (including but not limited to warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, medications that can affect electrocardiogram test results, other investigational drugs ) * Women who are pregnant or breastfeeding * Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. * Patients unwilling to comply with the protocol. * Known diagnosis of human immunodeficiency virus (HIV) infection Other protocol-defined inclusion/exclusion criteria may apply

NCT_ID NCT00109707

Study_NameA Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

Study Objectives Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer patients who takes LHRH antagonist and anti androgen Conditions: Prostate Cancer, Osteoporosis Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * pathologic confirmation of prostate cancer * patients who are taking LHRH antagonist or anti- androgen or both of them within 6 months since starting. Exclusion Criteria: * patients who are hard to be analysed by limitation of chart record according to investigators'discretion * patients who already have been registered in this study

NCT_ID NCT01025479

Study_NamePrevalence of Osteoporosis in Korean Prostate Cancer Patients Who is Receiving LHRH Agonist and/or Anti-androgen Agent

Study Objectives Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway. Conditions: Ovarian Cancer, Peritoneal Cancer Intervention / Treatment: DRUG: Niraparib Location: Norway Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients enrolled in the individual patient access program since 2017. * Patients who have received at least one dose of niraparib will be included. * Patients will be identified and recruited from the following participating sites: Oslo University Hospital, Haukeland University Hospital, Stavanger University Hospital, St. Olavs Hospital, University Hospital of Northern Norway and Sørlandet sykehus.

NCT_ID NCT04785716

Study_NameReal-life Use of Niraparib in a Patient Access Program in Norway

Study Objectives This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal lesions. Conditions: Stomach Neoplasms Intervention / Treatment: DRUG: Esomeprazole, DRUG: No PPI treatment Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Female or male aged >=18 years. * Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy. Exclusion Criteria: * Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator. * The ASA classification of physical status >= 4 as judged by the investigator. * Severe hepatic disease or renal disease * Ability to understand and the willingness to sign a written informed consent document. * Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator. * Haemorrhagic disorder. * Patients who had a history of gastrectomy or a recurrent lesion. * Known or suspected hypersensitivity to any component of any PPI . * Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine. * Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator. * Known or suspected alcohol, drug or medication abuse. * Any condition associated with poor compliance as judged by the investigator. * Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment. * Involvement in the planning and conduct of the study. Previous enrollment in the present study.

NCT_ID NCT02730533

Study_NameThe Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

Study Objectives Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar® in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment cycle between days 7 \& 14 in pts w progressive/recurrent GBM To obtain preliminary response rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM Conditions: Glioblastoma, Gliosarcoma Intervention / Treatment: DRUG: Temodar and O6-Benzylguanine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pts have histologically proven supratentorial GBM * Pts have recurrent/progressive MG. If pt received stereotactic radiosurgery / brachytherapy as part of their prior therapy, then histologic confirmation of recurrence/metabolic imaging consistent w recurrent tumor is recommended but not mandated * There must be measurable disease on contrast-enhanced magnetic resonance imaging study / CT scan performed <2wks of study drug administration * Interval of >12 wks between completion of XRT & enrollment on protocol * Interval of >4 wks between prior chemo & enrollment on protocol unless there is unequivocal evidence of tumor progression * Interval of >2 wks between prior surgical resection & enrollment on protocol unless there is unequivocal evidence of tumor progression * Age >18 yrs * KPS >70 percent * Following baseline study will be required <1wk of study drug administration: serum creatinine < 1.5 x ULN & Hematologic Status * Following baseline studies will be required <1wk of study drug administration: absolute neutrophil count >2000 cells/microliter; platelet count >125,000 cells/microliter * Following baseline studies will be required <1 wk of study drug administration: serum SGOT & total bilirubin < 2.5 x ULN * Signed informed consent, approved by IRB, will be obtained prior to initiating treatment * Pts w Reproductive Potential: Pts must agree to practice effective birth control measures while on study & for 2 months after completing therapy Exclusion Criteria: * Pregnant/breast feeding women/ women/men w reproductive potential not practicing adequate contraception. Therapy may be associated w potential toxicity to fetus/child that exceeds mini risks necessary to meet health needs of mother * Prior treatment w O6-BG + Temozolomide in combo * Active infection requiring intravenous antibiotics * Known diagnosis of HIV infection * Pts w history of another primary malignancy that is currently clinically significant/currently requires active intervention * Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition * Pts who have received investigational drugs <2 wks prior to start on study drug/have not recovered from side effects of such therapy.

NCT_ID NCT00612989

Study_NamePh I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM

Study Objectives A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 after Oral Administration in Healthy Volunteers Conditions: Chemotherapy-Induced Neutropenia Intervention / Treatment: DIETARY_SUPPLEMENT: high-fat diet, DRUG: EC-18 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Healthy adult aged between 19 and 45 years, inclusive, at the time of providing the informed consent form * body weight: >= 55kg(male), >= 50kg(female) * BMI: 18.5 kg/m2 ≦ BMI < 25.0 kg/m2 [BMI(body mass index) = Body weight (kg)/[height (m)]2 ] * in female subjects, the result of serum β-hCG pregnancy test comes out negative at screening, urine β-hCG test comes out negative before taking medication during the period set by this protocol have to be included one of the below conditions. * postmenopausal(no natural menstruation at least 2 years) * surgically sterile(hysterectomy or bilateral ovariotomy, tubal ligation or sterile condition by other ways) * sterility of male partner before screening(proof the azoospermia after vasectomy), and this is the only partner of the subject. * agree with using a proper and continuous method of contraception start on 14 days(at least) before the1st IND administration and for 28 days(at least) after the last IND administration * proper contraception means physical barrier method including condom, contraceptive diaphragm or cervix cap, do not use a hormones including contraceptive or oral contraceptive during the study. * if the male have a sex life with childbearing aged female, maintain proper contraception during the study and for 28 days after the last IND administration, agree with "do not donate the sperm"(if the female partner is infertility, above contraceptions are not necessary) * Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial Exclusion Criteria: * Hypersensitivity to a drug containing an ingredient of the investigational product(EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity * Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records * Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records * Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history * (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON®-TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tuberculosis * Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption, etc.

NCT_ID NCT02700360

Study_NameEvaluation of the Food Effect on the Safety, Tolerability, PK of EC-18 After Oral Administration in Healthy Volunteers

Study Objectives The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress. Conditions: Breast Cancer, Adherence, Medication Intervention / Treatment: OTHER: STRIDE, OTHER: Medication Monitoring Control Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Female * Age >= 21 years * Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer * Within 1 week-36 months of starting adjuvant endocrine therapy * Ability to read and respond in English * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 * Currently taking adjuvant endocrine therapy (i.e. if took recent break, has taken within the past 2 weeks) * Completed primary treatment (i.e., chemotherapy, surgery, and/or radiation) for early-stage breast cancer * Indicates a score >=4 on one of the three NCCN adapted distress thermometer study screening questions Exclusion Criteria: * Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year * Cognitive impairment that prohibits participation in the study * Enrollment in a different clinical trial for breast cancer * Current participation in formal group psychotherapy or other psychosocial intervention trial * Undergoing primary treatment for other cancer (i.e., advanced stage cancer)

NCT_ID NCT03837496

Study_NameSmall-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors

Study Objectives Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. Primary objective is to determine overall response rate. The secondary objectives are: * to assess overall safety, * to assess duration of response, progression free survival, and overall survival. Clinical benefit and pharmacokinetics parameters are also evaluated. Conditions: Leukemia, Lymphocytic, Chronic Intervention / Treatment: DRUG: alvocidib Location: Germany, United States, United Kingdom, Australia, Italy, Netherlands, Puerto Rico, Belgium, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient must have documentation of histologically confirmed and measurable Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL; * Patient must have symptomatic and progressive disease; * Patient must have received prior alkylating agent(s) and be fludarabine refractory; * Patient must have the adequate organ functions; * Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0 <= age <= 2; Exclusion Criteria: * Patient with de novo PLL; * Patient with secondary malignancy that will limit survival <=5 years; * Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant <=12 months; * Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry; * Patient with known history of glucose-6-phosphate dehydrogenase deficiency; * Patient with autoimmune hemolytic anemia; * Patient with known Central Nervous System involvement; * Patient with active, uncontrolled serious bacterial, viral or fungal infections The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

NCT_ID NCT00464633

Study_NameAlvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)

Study Objectives Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma Intervention / Treatment: DRUG: Dasatinib, OTHER: Laboratory Biomarker Analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report * All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT * Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Patients must not be eligible for a higher priority GOG protocol, if one exists; in general, this would refer to any active GOG Phase III protocol for the same patient population * Patients who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2; patients who have received two prior regimens must have a GOG Performance Status of 0 or 1 * Recovery from effects of recent surgery, radiotherapy, or chemotherapy * Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI). * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted * Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration; six weeks for patient previously treated with monoclonal antibodies * Prior therapy * Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment * Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition: * Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa * Note: patients on this non-cytotoxic study are allowed to receive additional cytotoxic chemotherapy for management of recurrent or persistent disease, as defined above * Patients must have NOT received any non-cytotoxic therapy for management of recurrent or persistent disease; patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen * Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to CTCAE v 3.0 grade 1 * Platelets greater than or equal to 100,000/mcl * Hemoglobin greater than or equal to 10 g/dL * Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1 * Bilirubin less than or equal to 1.5 x ULN, CTCAE v3.0 grade 1 * SGOT and alkaline phosphatase less than or equal to 2.5 x ULN, CTCAE v3.0 grade 1 * Mg++, CA++, phosphate, K+, Na corrected to WNL * PT/INR, PTT less than or equal to 1 - 1.5 x ULN, CTCAE v 3.0 grade 1 except for patients on therapeutic anticoagulation * Neuropathy (sensory and motor) less than or equal to CTCAE v 3.0 grade 1 * QTc interval on electrocardiogram must be less than or equal to 450 msec * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients must meet pre-entry requirements as specified in section 7.0 * Patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least 4 weeks following completion of protocol therapy * Patients must not be receiving any other investigational agent * Patients must be able to swallow whole pills Exclusion Criteria: * Patients who have had previous treatment with dasatinib * Patients who have received radiation to more than 25% of marrow-bearing areas * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last five years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease * Patients cannot take St. John's Wort or drink grapefruit juice while on study treatment (discontinue St. John's Wort at least five days before starting dasatinib) * Patients receiving IV bisphosphonates agree that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia, and may be restarted only if any hypocalcemia has been corrected * Patients who have a history of cardiac disease: * Uncontrolled angina, congestive heart failure (CHF) or myocardial infarction (MI) within six months prior to study entry; * Diagnosed congenital long QT syndrome; * Clinically significant ventricular arrhythmias (such as ventricular tachycardia [VT], ventricular fibrillation [VF], or Torsades de pointes) * Patients with hypokalemia or hypomagnesemia if it cannot be corrected to within normal limits prior to dasatinib treatment * Patients who have a history of significant bleeding disorder unrelated to cancer including: * Bleeding diathesis, congenital or acquired within one year prior to initiating protocol therapy (e.g., von Willebrand's disease, acquired anti-factor VIII antibodies); * Significant GI bleeding within three months prior to initiating protocol therapy * Dasatinib is metabolized primarily by the CYP3A4 liver enzyme; consideration should be given to using alternative medications not impacting CYP3A4 while on dasatinib therapy * Patients may not be receiving any prohibited potent CYP3A4 inhibitors; for these drugs, a wash-out period of >= 7 days is required prior to starting dasatinib treatment * Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes; a wash-out period of >= 7 days is required for the following drugs prior to starting dasatinib treatment: * Quinidine, procainamide, disopyramide * Amiodarone, sotalol, ibutilide, dofetilide * Erythromycin, clarithromycin * Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide * Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine * The concomitant use of H2 blockers and proton pump inhibitors (PPIs) with dasatinib is not recommended (e.g., famotidine, omeprazole); the use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy; if antacid therapy is needed, the antacid dose should be administered two hours before or after the dose of dasatinib * Therapeutic anticoagulation is not contraindicated, but for those patients on therapeutic anticoagulation, alteration in coagulation parameters is expected following initiation of dasatinib. For patients on therapeutic anticoagulation, coagulation parameters should be assessed weekly for the first cycle following initiation of dasatinib, weekly for the first cycle following a dose reduction, and weekly for a minimum of two weeks after stopping dasatinib. Warfarin is permitted for prophylaxis or treatment of thrombosis * Note: Low molecular weight heparin is permitted provided the patient's PT/INR is =< 1.5; for patients on anticoagulation, coagulation parameters should be assessed weekly for the first cycle following initiation of dasatinib, weekly for the first cycle following a dose reduction, and weekly for a minimum of two weeks after stopping dasatinib * Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator

NCT_ID NCT00671788

Study_NameA Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Study Objectives The objective of this phase I study is to determine the maximum tolerated dose (MTD) of combination therapy of paclitaxel and everolimus in small cell lung cancer patient with previous treatment history. Conditions: Small Cell Lung Cancer Intervention / Treatment: DRUG: taxol plus everolimus Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically or cytologically confirmed small cell lung cancer * Regarding a limited disease, the disease in a patient, who had concurrent chemoradiation therapy before, is relapsed or progressing, the patient should have received the first line platinum-based anticancer therapy. The disease should be progressing/relapsed during or after the previous treatment. * Regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed. * Patient with asymptomatic or treated brain metastasis. * Patients without current concomitant chemotherapy * Patients without current concomitant radiotherapy * Patients who are not receiving chronic treatment with steroids or another immunosuppressive agent. * Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST). * Patients aged >= 18 years * ECOG performance status 0 <= age <= 2 * Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; hemoglobin > 9g/dL; -; total bilirubin <=1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance >= 50mL/min. * Patients who signed and dated the informed consent form prior to specific study procedures. * Patients who can comply with the scheduled follow-up and toxicity management procedure.' Exclusion Criteria: * Patients with history of treatment with mTOR inhibitors * Pregnant with gastrointestinal problem impairing absorption of drugs * Patients who could not use appropriate method of contraception * Pregnant or feeding patients * Other medically ill patients * Severe heart/pulmonary disease * DM patients * Other malignancy except cured skin cancer or uterine cervix carcinoma in situ * High cholesterolemia greater than grade 3 * Patients with symptomatic brain metastasis * Chronic hepatitis or liver cirrhosis (patients with HBsAg positive, IgM anti-HBc positive or HCV Ab positive) * Patients receiving immunosuppressant

NCT_ID NCT01079481

Study_NameCombination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer

Study Objectives This is an approach which can inflict significant toxicity. An alternative is to block expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach which could reduce toxicity to the host while maximizing destruction of the oncogene-dependent malignant cells. Conditions: Leukemia, Lymphoma, Non-Hodgkin Intervention / Treatment: DRUG: Atorvastatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * > 18 years * Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin's Lymphoma (NHL) subtypes: * Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL) * Extranodal marginal zone B-cell lymphoma * Nodal marginal zone B-cell lymphoma * Splenic marginal zone B-cell lymphoma * Treatment criteria * Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR * Prior treatment: watchful waiting currently appropriate o OR * Refractory disease * Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma) * CT chest (date) * CT abdomen (date) * CT pelvis (date) OR * Staging within 4 weeks prior to enrollment (CLL: CT not required) * Total white blood cell count (WBC) (Value) (date) * Absolute lymphoma cell count (ALC) (Value) (date) * Measurable disease (Site) (Size) OR * CLL (only): elevated absolute lymphoma cell count * Disease amenable to biopsy (must check at least one): * Circulating tumor cells * Positive bone marrow * Palpable involved site (such as lymph node) measuring > 1.5 cm * Eastern Cooperative Oncology Group performance status <2 (Karnofsky >60) * Life expectancy of greater than 3 months * Patients must have adequate organ and marrow function * Absolute neutrophil count > 1,000/uL * Platelets > 30,000/uL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ratio < 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential must have negative BetaHCG at enrollment Exclusion Criteria: * Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study * Not recovered from adverse events due to agents administered more than four weeks earlier * Has stable low grade lymphoma has had rituximab within 3 months Patient with relapsed or refractory disease has had rituximab within 1 month * Not recovered from adverse events due to surgery performed 4 weeks earlier * Receiving any other investigational agent. Known brain metastases * Taken any statin within the past 6 months prior to enrollment in the trial * Currently abuses alcohol * Currently takes cyclosporin or gemfibrozil Patient has a prior history of rhabdomyolysis * Has uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant: Patients are not excluded if they are breastfeeding at the time of enrollment, but breastfeeding should be discontinued if the mother is treated with atorvastatin. * HIV-positive patients receiving combination anti-retroviral therapy

NCT_ID NCT00185731

Study_NamePhase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma

Study Objectives Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma. The trial did not progress into Phase II due to the suboptimal tolerability of the combination treatment of sotrastaurin and everolimus in the Phase Ib part of the study. There were no serious safety concerns associated with this combination. Conditions: CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma Intervention / Treatment: DRUG: AEB071, DRUG: Everolimus Location: Germany, United States, Italy, Taiwan, Netherlands, France, Korea, Republic of, Hong Kong Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female >=18 years. * Diffuse DLBCL with activating mutations in CD79 (A or B subunits) or ABC-subtype DLBCL (CD79 wildtype or CD79 mutant). DLBCL that arose from transformed indolent lymphoma is allowed. * Prior treatment and relapse following chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible or who did not respond to chemotherapy may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH. There is no limit to number of prior therapies allowed. * May be treated with localized radiation as long as measurable or evaluable disease remains at untreated sites. * WHO performance status of <= 2. * A representative FFPE tumor sample must be available for molecular testing along with a corresponding pathology report. An archival tumor sample may be submitted. However, if not available, a new tumor biopsy obtained for the purpose of this study must be submitted instead. Exclusion Criteria: * Treatment with strong inducers or inhibitors (medications and herbal supplements) of cytochrome P450 3A4/5 (CYP3A4/5), or CYP3A4/5 substrates with a QT prolongation risk that cannot be discontinued at least 7 half-lives (or if the half-life is unknown,14 days) prior to study drug treatment. * Impaired cardiac function or clinically significant cardiac diseases. * Impairment of GI function or GI disease that could interfere with the absorption of AEB071 or everolimus. * Severe systemic infections, current or within the two weeks prior to initiation of AEB071. * Kown history of HIV. * Poorly controlled diabetes as defined by a fasting serum glucose > 2.0 x ULN. * Evidence of current CNS involvement. * Significant symptomatic deterioration of lung function.

NCT_ID NCT01854606

Study_NameSafety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

Study Objectives Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cancer patients. The investigators primary specific aim will focus on determining the magnitude of response to placebo acupuncture versus placebo pills on hot flashes (HFs). Conditions: Hot Flashes Intervention / Treatment: DRUG: Gabapentin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Women >= 18 years with a history of Stage I, II or III breast cancer for at least 12 months. * Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history; * Experienced at least two hot flashes daily over the seven-day screening period as based on the Daily Hot Flash Diary. * Hot flashes have been present for at least a month before study entry. * Willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal. Exclusion Criteria: * Having metastatic breast cancer ( IV) * Currently on chemotherapy or radiation therapy as adjuvant treatment * Started hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks. * Started or changed with treatments for hot flashes, such as SSRIs or clonidine within the last 4 weeks; or plan to change or terminate these therapies in the next 14 weeks. * Current use of estrogen and/or progestin. * Pregnancy * Breast feeding * Bleeding disorder or current use of warfarin or heparin by patient history because of the use of needles. * Previous use of gabapentin for hot flashes. * Current use of any anti-convulsant. * Renal dysfunction defined as serum creatinine concentration above 1.25 times the upper limit of normal * Known allergy to gabapentin.

NCT_ID NCT01005108

Study_NameAcupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Study Objectives Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1 and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every 2 cycles of chemotherapy. Conditions: Stomach Neoplasms Intervention / Treatment: DRUG: Irinotecan, Oxaliplatin, TS-1 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease * Age >=18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2 * Disease status must be that of measurable disease as defined by RECIST criteria:Measurable lesions: Lesions that can be accurately measured in at least one dimension by any of the following: - CT of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT- Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm * No prior treatment for recurrent or metastatic disease; prior adjuvant/neoadjuvant therapy is allowed if at least 12 months have elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study. However, prior oxaliplatin and/or irinotecan as adjuvant therapy are not allowed. * Adequate major organ function including the following: Hematopoietic function: ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin 1.5 mg/dl, AST/ALT levels 2.5 x UNL ( 5 x UNL if liver metastases are present)Renal function: serum creatinine UNL * Patients should sign a written informed consent before study entry Exclusion Criteria: * Prior history of peripheral neuropathy * Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality * Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy * Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix * Psychiatric disorder that would preclude compliance * Pregnant, nursing women or patients with reproductive potential without contraception * Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine

NCT_ID NCT00512681

Study_NameA Phase II Study of Irinotecan, Oxaliplatin, Plus TS-1 in Untreated Metastatic Gastric Cancer

Study Objectives The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease. Conditions: B-cell Acute Lymphoblastic Leukemia Intervention / Treatment: DRUG: Blinatumomab Location: Poland, Germany, Spain, United Kingdom, Italy, Netherlands, Austria, Belgium, Russian Federation, Romania, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks * Presence of minimal residual disease at a level of >= 10^-3 * Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment * Negative human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test * Negative pregnancy test in women of childbearing potential * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: * Presence of circulating blasts or current extra-medullary involvement by ALL * History of relevant central nervous system (CNS) pathology or current CNS pathology * Prior allogeneic hematopoietic stem cell transplant (HSCT) * Eligibility for treatment with tyrosine-kinase inhibitors (TKI) * Systemic cancer chemotherapy within 2 weeks prior to study treatment * Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment * Previous treatment with blinatumomab

NCT_ID NCT01207388

Study_NameConfirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

Study Objectives Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor cells. Phase I trial to study the effectiveness of monoclonal antibody therapy given with sargramostim and interleukin-2 in treating children with neuroblastoma who have just completed bone marrow or peripheral stem cell transplantation Conditions: Disseminated Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma Intervention / Treatment: BIOLOGICAL: monoclonal antibody Ch14.18, DRUG: isotretinoin, BIOLOGICAL: aldesleukin, BIOLOGICAL: sargramostim Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Must have recently completed a course of myeloablative therapy followed by autologous stem cell (bone marrow or peripheral blood) rescue (ASCT) * Patients must have a diagnosis of neuroblastoma based upon tumor histology or bone marrow metastases and elevated urine catecholamine metabolites; greater than 98% of neuroblastomas are GD2-positive without intratumor heterogeneity, so these tumors will not be immunostained prior to study entry * Patients entered on CCG-3951 may become eligible following the third course of high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue; patients treated on institutional (local) protocols of high-dose chemotherapy with PBSC rescue may also become eligible after one or more courses of PBSC rescue * Patients must enter onto study within 8 weeks after the total absolute phagocyte count [neutrophils (segs + bands) + monocytes] is > 1,000/uL; the APC criteria include counts obtained while on G-CSF therapy * Patients must have a performance status of 0, 1 or 2 and patients must have a life expectancy of >= 2 months * Serum creatinine =< 1.5 x normal, or creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 ml/min/1.73 m^2 * Total bilirubin =< 1.5 x normal * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x normal * Veno-occlusive disease, if present, should be stable or improving * Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by gated radionuclide study * Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) > 60% of predicted by pulmonary function test * For children who are unable to do pulmonary function tests (PFTs), no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% on room air * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * Central nervous system (CNS) toxicity < grade 2 * Patients must have a double lumen catheter or single lumen and peripheral IV so that interleukin (IL)-2 and ch14.18 can be given separately * Patients who remain evaluable for response on Phase II/III studies (i.e. CCG-3891) are not eligible for this study; however, patients treated on Phase I studies (i.e. CCG-3951) and patients who are no longer evaluable on Phase II/III studies (i.e. progressive disease following therapy) will be eligible * Patients who were previously treated with antibody 14.G2a or ch14.18 are ineligible for this study * Patients requiring chronic use of corticosteroids are ineligible * Corticosteroid, immunosuppressive drugs, myelosuppressive chemotherapy, and retinoic acid must not be given within 14 days prior to study entry * Radiation therapy must not be given within seven days prior to study entry or during therapy * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, FDA, and NCI requirements for human studies must be met

NCT_ID NCT00005576

Study_NameMonoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma

Study Objectives This randomized phase II trial studies how giving a drug called levocetirizine to patients with colorectal cancer affects their tumor response to capecitabine and bevacizumab. Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA synthesis and repair (cell division and survival). Bevacizumab is a monoclonal antibody that blocks the ability of tumors to grow and spread by inhibiting the growth of blood vessels that feed them. Patients with colorectal cancer can develop a resistance to the effects of bevacizumab. Levocetirizine may decrease tumor resistance to bevacizumab. Giving bevacizumab, capecitabine, and levocetirizine dihydrochloride together may be an effective treatment for refractory colorectal cancer. Conditions: Colorectal Neoplasms Intervention / Treatment: DRUG: Bevacizumab, DRUG: Capecitabine, DRUG: Levocetirizine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patient must have histologically or cytologically confirmed refractory colorectal cancer (CRC). * Patient must have measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >=10 mm with CT scan, as >=20 mm by chest x-ray, or >=10 mm with calipers by clinical exam. * Patient must have documented progressive disease within 3 months of his/her most recent cycle of chemotherapy. * Patient must be refractory to or intolerant of prior therapy with a fluoropyrimidine, oxaliplatin, irinotecan, and/or anti-angiogenic therapy. Patients with K-RAS wild type tumors must have received an epidermal growth factor receptor (EGFR) inhibitor such as cetuximab or panitumumab. * Patient must be >= 18 years. * Patient must have an ECOG performance status <= 2 * Patient must have normal bone marrow and organ function as defined below: * Absolute neutrophil count >= 1,500/mcl * Platelets >= 100,000/mcl * Total bilirubin <= 2.0 x IULN * AST(SGOT)/ALT(SGPT) <= 3.0 x IULN * Patients must have adequate renal function prior to chemotherapy defined as serum creatinine <= 2.0 mg/dl OR Creatinine clearance >= 60 mL/min/1.73 m2 for patients with creatinine levels above 2.0 * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Patient must be able to understand and willing to sign an IRB approved written informed consent document. Exclusion Criteria: * Patient must not have a history of other malignancy <= 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. * Patient must not be receiving any other investigational agents. * Patient must not have known active brain metastases. Patients with previously treated brain metastases are eligible. Patients with known brain active metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to levocetirizine, capecitabine, bevacizumab, or other agents used in the study. * Patient must not have known dihydropyrimidine dehydrogenase (DPD) deficiency or severe renal impairment (creatinine clearance below 30 mL/min by Cockcroft and Gault formula) as this would prelude use of capecitabine. * Patient must not have known proteinuria >= 500mg/24 hours. * Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patient must not be pregnant and/or breastfeeding. Patient must have a negative urine pregnancy test within seven days of study entry. * Patient must not be known to be HIV-positive on combination antiretroviral because of the potential for pharmacokinetic interactions with levocetirizine, capecitabine, and bevacizumab. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

NCT_ID NCT01722162

Study_NameLevocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer

Study Objectives Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer. Conditions: Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer Intervention / Treatment: DRUG: gemcitabine hydrochloride, DRUG: paclitaxel, DRUG: tipifarnib, RADIATION: radiation therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas * Residual disease after resection (R1 or R2, microscopic or macroscopic) allowed * No metastases in major viscera * No peritoneal seeding or ascites * Biliary or gastroduodenal obstruction must have drainage before starting study therapy * Radiographically assessable disease encompassable within a single irradiation field (15 by 15 cm maximum) * Performance status - Zubrod 0 <= age <= 1 * Granulocyte count at least 1,800/mm^3 * Platelet count at least 100,000/mm^3 * ALT less than 3 times upper limit of normal * Bilirubin less than 2.0 mg/dL * Creatinine less than 3.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder * No significant infection or other medical condition that would preclude study * No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer * No other concurrent cytotoxic agents * See Disease Characteristics * No prior radiotherapy to the planned field * No other concurrent radiotherapy * See Disease Characteristics * No other concurrent investigational agents

NCT_ID NCT00026104

Study_NameCombination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer

Study Objectives This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason. Conditions: Non-Squamous Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: erlotinib [Tarceva] Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Adult participants, >= 18 years * Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small cell lung cancer (NSCLC) * Presence of epidermal growth factor receptor (EGFR) mutations * Previously untreated with any systemic anti-neoplastic therapy for advanced disease * Last dose of a prior systemic anti-neoplastic therapy for early-stage disease >= 4 weeks before study start, and patient recovered from acute toxicities of any previous therapy * A life expectancy of at least 12 weeks * Able to comply with the study and its follow-up procedures * Female participants had to be postmenopausal (24 months of amenorrhea), surgically sterile or agree to use a physical method of contraception. Male participants had to be surgically sterile or agree to use a barrier method of contraception. Women with an intact uterus (unless amenorrhoeic for the last 24 months) had to have a negative pregnancy test (urine or serum) within 3 days prior to erlotinib treatment initiation in the study. Male and female participants had to use effective contraception during the study and for a period of 90 days following the last administration of erlotinib. Acceptable methods of contraception included an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) Exclusion Criteria: * Pregnant or breast feeding women * Granulocyte count <1.5 x 109/L and platelet count <100*10^9/L * Serum bilirubin >1.5 upper limit of normal (ULN) * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 * ULN (or >5 * ULN if clearly attributable to liver metastasis) * Serum creatinine >1.5 ULN or creatinine clearance <60 mL/min * Known allergy or other adverse reaction to study drug or any other related compound * Any significant unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease) * Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy) * Newly diagnosed or not yet definitively treated (i.e. stable disease >= 2 months) CNS metastases or spinal cord compression * Any significant ophthalmological abnormality, especially those likely to increase the risk of corneal epithelial lesions (the use of contact lenses is not recommended during the study) * Participants who could not take oral medication, who required intravenous alimentation, had had prior surgical procedures affecting absorption, or had active peptic ulcer disease * Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured

NCT_ID NCT01174563

Study_NameA Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

Study Objectives TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. The objectives of this study are to determine the safety profile of TRX-818 including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) and determine the recommended dose and regimen(s) to initiate Phase 2. Conditions: Carcinoma, Advanced Cancer Intervention / Treatment: DRUG: TRX-818 capsules Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Tumor eligibility: Histologically confirmed advanced malignancies refractory to standard of care therapy, or for whom no standard of care therapy is available. * Solid tumors must have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy. Leukemia, lymphomas and multiple myeloma must have measurable disease as per response criteria. * Female or male, 18 years or older. * Eastern Cooperative Oncology Group performance status 0 to 2. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1 (except alopecia). * Adequate organ function as defined by the following criteria: * Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) <=3 x upper limit of normal (ULN), or AST and ALT <=5 x ULN if liver function abnormalities are due to underlying malignancy * Total serum bilirubin <=1.5 x ULN (except for patients with documented Gilbert's syndrome) * Absolute neutrophil count (ANC) >= 1500/µL * Platelets >= 90,000/µL * Hemoglobin >= 9.0 g/dL * Serum creatinine <=2.0 x ULN * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: Patients presenting with any of the following will not be included in the trial: * Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment. * Prior high-dose chemotherapy requiring hematopoietic stem cell rescue except for patients with lymphoma or myeloma. * Current treatment on another clinical trial. * Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks. * Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6 month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted. * Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). * Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg Per oral (PO) daily for deep vein thrombosis prophylaxis is allowed). * Known human immunodeficiency virus infection. * Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. * Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.

NCT_ID NCT02507544

Study_NameA Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer