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Study Objectives This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer. Conditions: Pancreatic Neoplasms Intervention / Treatment: DRUG: Gemcitabine with escalating ascorbic acid 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: * Normal G6PD status * Histologically or cytologically diagnosed pancreatic adenocarcinoma. * Disease extent documented by CT scan (radiologically measurable disease is not required) * Ambulatory patient without evidence of spinal cord compression * No prior chemotherapy for metastatic disease * Failed curative therapy or patient ineligible for definitive curative therapy * Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment. * If post-therapy, must have disease progression since that treatment * If treated with prior radiation therapy, disease must be outside of the radiation fields * No currently active second malignancies unless it is a non-melanoma skin cancer * Women must be non-pregnant and non-lactating * ECOG performance of 0, 1, or 2 * Granulocytes at least 1,500 / ul * Platelets at least 100,000 / ul * Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min * Total bilirubin less than 2 times the upper limit of normal * AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal * PT INR less than 1.5 (unless the patient is on full dose warfarin) * Patient must be at least 18 years of age * Patient must be able to understand consent process, the research study, and be able to sign the consent document Exclusion Criteria: * A psychiatric disorder by history or examination that would prevent completion of the study * ECOG performance of 3 or 4 * Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis. * Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs * Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)

Study Objectives The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years. Conditions: Chemotherapy Induced Nausea and Vomiting Intervention / Treatment: DRUG: granisetron transdermal system, DRUG: Granisetron IV Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * 13 to 17 years of age inclusive at screening. * Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate. * Written patient assent (as appropriate). * Confirmed malignancy. * Scheduled to receive 2 or more cycles\* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment. * Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis. * The cycles of chemotherapy must be consecutive (i.e. one followed by the other) but do not have to be the first and second cycle of a line of treatment. Exclusion Criteria: * Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster. * Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study. * Patients with a known history or predisposition to cardiac conduction interval abnormalities, including QT Syndrome, or known family history of long QT Syndrome or taking medications that are known to prolong the QT interval. * Patients scheduled to have routine surgery during the study duration. * Patients with a life expectancy of < 6 months. * Scarring or significant skin disease on both upper arms. * Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening. * Patients who are known or thought to be sexually active must use effective birth control.\*\* * Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments. * Any conditions associated with non-compliance. * Effective birth control includes absolute abstinence, or double barrier birth control methods, i.e. condom and one of the following: combined oral contraceptive, diaphragm, depot contraceptive injection.

Study Objectives The study will be carried out at the hospital of the medical school of sao paulo (HC-FMUSP) and the goal is to compare the effects of the administration of myo-inositol in relation to the effects of metformin in women with Polycystic Ovary Syndrome and insulin resistance or glucose intolerance. Menstrual cycle, hyperandrogenism, chronic inflammatory process, carbohydrate metabolism, hepatic steatosis will be evaluated. In total, 60 women in the reproductive period, with a variable age between 18 and 36 years old will be recruited and randomized in two groups: intervention- myo-inositol for 6 months, control group will use metformin also for 6 months. Conditions: Polycystic Ovary Syndrome, Resistance, Insulin, Glucose Intolerance Intervention / Treatment: DRUG: Myo-inositol, DRUG: Metformin Location: Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance. Exclusion Criteria: * Previous use of any hormonal treatment in the past three months; * Other causes of anovulation; * Gynecological or other associated conditions (endometriosis, adenomyosis or diabetes mellitus); * FSH (Follicle Stimulating Hormone) > 15 Ul / L (2nd to 5th day of the cycle); * Beta-hcG (human chorionic gonadotropin) positive (pregnancy).

Study Objectives The goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking. Conditions: Cervical Cancer, Tobacco Use, Smoking Cessation Intervention / Treatment: BEHAVIORAL: Self-Help Materials, DRUG: Nicotine Patch, BEHAVIORAL: REDCap, PROCEDURE: Saliva Test, BEHAVIORAL: Telephone Counseling Sessions, DRUG: Nicotine lozenge Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * 18 years of age or older * Self-reported current smoker * History of cervical cancer or high-grade cervical dysplasia * Has a working telephone number * Has a valid home address * Speaks English, Spanish or both languages Exclusion Criteria: * Current use of tobacco cessation medications * Self-report of being pregnant or lactating * Another household member enrolled in the study * Contraindication for nicotine patch use

Study Objectives The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease. Conditions: Carcinoma, Renal Cell Intervention / Treatment: DRUG: Sorafenib (Nexavar, BAY43-9006), DRUG: Placebo Location: Hungary, Canada, United States, France, Poland, Israel, Italy, Netherlands, Ukraine, United Kingdom, South Africa, Russian Federation, Spain, Brazil, Belgium, Chile, Germany, Australia, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented * Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization * Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) * Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 * Patients who have adequate coagulation, liver and kidney functions Exclusion Criteria: * Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors * Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry * Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure * Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C * Patients with a history or presence of metastatic brain or meningeal tumors * Patients with seizure disorder requiring medication (such as anti-epileptics) * History of organ allograft or bone marrow transplant of stem cell rescue * Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control * Patients who have three or more of the following: * ECOG performance status greater than or equal to 2, * Abnormally high lactate dehydrogenase, * Abnormally high serum hemoglobin, * Abnormally high corrected serum calcium, * Absence of prior nephrectomy * Excluded therapies and medications, previous and concomitant: * Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates * Significant surgery with 4 weeks of start of study * Investigational drug therapy during or within 30 days * Concomitant treatment with rifampin or St. John's Wort * Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors * Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors

Study Objectives The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy induced toxicity profile of this combination; time to progression; and patient reported symptom burden. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Pemetrexed and Gemcitabine plus Bevacizumab 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: * Patient provides voluntary written informed consent before performance of any study-related procedure not part of normal medical care. * Patient ≥ 65 years of age with ECOG of 0 to 1 * Patient must have histologically/cytologically confirmed Stage IIIB/IV NSCLC. * Patient has measurable disease defined as at least 1 lesion that can be accurately measured in at least 1 dimension (by CT or MRI) \& used to assess response as defined by RECIST criteria. Tumors within a previously irradiated field will be designated nontarget lesions. * Patient has not received radiotherapy within 2 weeks(4 weeks required for brain metastases radiotherapy)of initial chemotherapy dosing for this study, and all acute toxicities due to prior radiotherapy have resolved prior to initial chemotherapy dosing. * Patient has a negative serum pregnancy test or has undergone hysterectomy at time of enrollment. * Greater than 12 weeks life expectancy. * Patient has recovered from any recent surgery for at least 30 days \& is free of active infection requiring antibiotics. * Patient must be willing/able to discontinue use of NSAIDS prior to study drug dosing. * Patient must be able to take folic acid, Vitamin B12, \& dexamethasone per protocol. * Patient must exhibit no greater than Grade 1 peripheral neuropathy. Exclusion Criteria: * Prior systemic or other concurrent chemo for metastatic NSCLC(Prior Tarceva is not allowed).Prior adjuvant chemo acceptable as long as > 12 months since completion and no prior pemetrexed, gemcitabine or bevacizumab. * Lung carcinoma of squamous cell histology(mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is acceptable.Patients with extrathoracic-only squamous cell NSCLC are eligible.Patients with only peripheral lung lesions (of any NSCLC histology) will also be eligible(a peripheral lesion is defined as a lesion in which the epicenter of the tumor is ≤ 2 cm from the costal or diaphragmatic pleura in a three-dimensional orientation based on each lobe of the lung and is > 2 cm from the trachea, main, and lobar bronchi). * Hemoptysis within 1 month prior to study enrollment * Ongoing treatment with full-dose warfarin or its equivalent i.e., unfractionated and/or low molecular weight heparin.(Low dose warfarin 1 mg given for prophylaxis is allowed). * Hypersensitivity to any component of Alimta, gemcitabine \&/or bevacizumab, \&/or cannot tolerate folic acid, corticosteroids or Vitamin B12 supplements. * Currently/have recently taken long-acting NSAID (Ibuprofen ≤ 400 mg QID acceptable) or aspirin (>325mg/day) within 5 days of initial pemetrexed administration. * Clinically significant pericardial/pleural effusion or ascites unless able to be drained before study entry. * Presence of third space fluid which cannot be controlled by drainage. * Core biopsy/other minor surgical procedure(excluding placement of a vascular access device)within 7 days prior to study enrollment. * Active infection or fever ≥ 38.5°C within 3 days of first scheduled day of protocol treatment. * Serious, non-healing wound, ulcer, or untreated bone fracture. * NYHA Grade II or greater CHF * Inadequately controlled hypertension (defined as systolic blood pressure > 150 \&/or diastolic blood pressure > 100mmHg on antihypertensive meds) * Any prior history of hypertensive crisis or hypertensive encephalopathy. * History of MI, CVA, TIA, or unstable angina within 6 months of study enrollment. * Significant vascular disease (aortic aneurysm, aortic dissection or recent peripheral arterial thrombosis.) * Symptomatic peripheral vascular disease * Known bleeding diathesis or coagulopathy * Presence of CNS(central nervous system) except for treated brain metastases. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging(MRI or CT)during the screening period.Anticonvulsants(stable dose)are allowed.Treatment for brain metastases may include whole brain radiotherapy(WBRT),radiosurgery(RS;Gamma Knife,LINAC,or equivalent)or a combination as deemed appropriate by the treating physician.Radiotherapy must be completed at least 4 weeks prior to study enrollment and all acute radiotherapy toxicities resolved.Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded. * A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study. * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment. * History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate specific antigen of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry. * Have received radiotherapy to more than 25% of their bone marrow. * Receiving concurrent investigational therapy or has received investigational therapy within 30 days of the first scheduled day of protocol treatment * Pregnant/lactating. * Any other medical condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate/participate in the study, or interfere with interpretation of the results. * History of allogeneic transplant. * Known HIV infection or Hepatitis B or C.

Study Objectives 1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy. 2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen. 3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen. Conditions: Myelodysplastic Disorders, Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative Disorders Intervention / Treatment: DRUG: FLUDARABINE, DRUG: CAMPATH 1H, DRUG: FK50, PROCEDURE: Stem Cell Collection and Infusion Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria * Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma. * Conditions that increase treatment related mortality (need one or more to be eligible): 1. Greater to or equal to 50 years of age. 2. EF of less than 45% 3. DLCO less than 50% of FEV1 50-75% of predicted value. 4. Diabetes Mellitus 5. Renal Insufficiency (but creatine clearance not less than 25ml/min). 6. Prior recent history of systemic fungal infection. 7. 3rd or greater remission of AML or ALL 8. More than 1 year of diagnosis (CML or Myeloma patients) 9. Multiple types of treatment regimens. (equal to or more than 3) 10. Prior autologous or allogeneic stem cell transplantation. 11. Significant grade III or IV neurologic or hepatic toxicity from previous treatment. 12. No matched sibling donor. * Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1) * Patient and/or responsible person able to understand consent. * Age between birth and 70 years. * For women of childbearing potential, negative pregnancy test. Exclusion criteria * Patient is pregnant, lactating or unwilling to use contraceptives * HIV positive patient * Uncontrolled intercurrent infection * Refractory AML, or ALL * Untreated Blast Crisis for CML * Uncontrolled High-grade lymphoproliferative disease/lymphoma. * Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater) * Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater) * Hemodialysis dependent * Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal. * Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months) * Active CNS disease from hematological disorder.

Study Objectives Chemotherapy regimens for pancreatic cancer can now stabilize a patient's cancer and/or place some patients in remission or partial remission. The challenge now is to find options for maintenance therapies that will improve survival and allow continued benefits with minimal toxicities and inconvenience to the patients. This study will determine the effects of one possible maintenance regimen. The study is being conducted to determine the effects that pembrolizumab with or without the addition of paricalcitol may have on pancreatic cancer. Half of the patients will be randomized to receive pembrolizumab + paricalcitol and half to receive pembrolizumab + placebo. Conditions: Pancreatic Cancer, Pancreas Adenocarcinoma, Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma Intervention / Treatment: DRUG: Pembrolizumab, DRUG: paricalcitol, DRUG: placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Be willing and able to provide written informed consent for the trial. * Be ≥ 18 years of age on day of signing informed consent. * Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis, who had obtained a best response of at least stable disease (SD) or a partial response (PR) for a period of 2 months with no further shrinkage of ≥ 30% on scan on their first line of chemotherapy for their advanced metastatic disease. Note: Patients that have had prior chemotherapy as adjuvant or neoadjuvant therapy are permitted. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale. * Able to submit an archival tumor specimen (primary or metastatic site) and a discussion is documented with trial investigator at screening that patient will consider providing tissue from a newly obtained core or excisional biopsy of a tumor lesion at baseline and a second biopsy 9 weeks after starting trial treatment, unless tumor is considered inaccessible or biopsy is otherwise considered not in the patients best interest. Participation in this trial is not contingent on patient consenting to optional tumor biopsies. * Demonstrate adequate organ function as defined in protocol, AND serum corrected calcium value must be ≤ Institutional Upper Limit of Normal (ULN) and ≥ 8.0 mg/dL, and phosphorus levels must be ≤ Institutional ULN and ≥ 2.5 mg/dL. * Female participants of childbearing potential should have a negative serum pregnancy test within 24 hours prior to receiving first dose of trial medication. * A female participant is eligible to participate if she is not pregnant , not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) as defined in protocol OR 2. A WOCBP who agrees to follow the contraceptive guidance in protocol during the treatment period and for at least 120 days after the last dose of trial treatment. * Male participants must agree to use a contraception as detailed in protocol during the treatment period and for at least 120 days after the last dose of trial treatment and refrain from donating sperm during this period. Exclusion Criteria: * Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 4 weeks of the first dose of trial treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. * Has a known history of active TB (Mycobacterium tuberculosis). * Hypersensitivity to pembrolizumab or paricalcitol or any of its excipients. * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to Cycle 1/Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle1/ Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent(s). Note: Patients with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the trial. Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability. * Has active autoimmune disease that has required systemic treatment in the 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, etc.) is not considered a form of systemic treatment. * Has history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. * Has a serum vitamin D level of ≥ 50 ng/mL * Currently taking a strong cytochrome P450 3A (CYP3A) inhibitors that cannot be discontinued prior to trial enrollment and for the duration of trial. This includes but is not is limited to: boceprevir clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has a known history of or is positive for Hepatitis B (e.g., HBsAg reactive) or Hepatitis C virus (e.g., HCV RNA \[qualitative\] is detected). Note: Without known history testing needs to be performed to determine eligibility. * Current, serious, clinically significant cardiac arrhythmias as determined by the investigator, or patient receiving a digitalis derivative. * Has received a live vaccine within 30 days of planned start of trial therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed

Study Objectives This randomized phase II trial studies how well pemetrexed disodium with or without erlotinib hydrochloride works in treating patients with stage IIIB-IV or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective with or without erlotinib hydrochloride in treating non-small cell lung cancer. Conditions: Bronchioloalveolar Carcinoma, Large Cell Lung Carcinoma, Lung Adenocarcinoma, Recurrent Non-Small Cell Lung Carcinoma, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Erlotinib Hydrochloride, OTHER: Laboratory Biomarker Analysis, DRUG: Pemetrexed Disodium Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must have histologically or cytologically confirmed advanced (stage IIIB with a malignant pleural effusion or stage IV disease) or recurrent nonsquamous NSCLC * Patients must have at least one measurable disease per RECIST criteria; all sites of disease must be assessed within 4 weeks prior to registration * Patient must have disease progression after one prior combinational chemotherapy and/or targeted therapy other than pemetrexed or an epidermal growth factor receptor (EGFR) ) tyrosine kinase inhibitor (TKI) (such as erlotinib, gefitinib, or a second generation EGFR TKI); prior monoclonal antibody against EGFR is allowed) for metastatic disease, or relapse while receiving adjuvant therapy, or within 12 months of completing adjuvant therapy * All patients will be screened for brain metastasis within 6 weeks prior to registration; patients with treated and stable brain metastases must have been treated with surgery and/or radiation and are asymptomatic and are no longer taking corticosteroids * Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky >= 60% * Absolute neutrophil count >= 1,500/uL * Hemoglobin >= 8.0 g/dL * Platelets >= 100,000/uL * Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), except in known hepatic metastasis, wherein may be =< 3.0 X ULN * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 3.0 x institutional ULN, except in known hepatic metastasis, wherein may be =< 5.0 X ULN * Creatinine clearance >= 45 mL/min for patients with creatinine levels above institutional normal * Patients must not be pregnant or breastfeeding since there is no information regarding the use of these agents in this population; a negative serum or urine pregnancy test is required within 14 days prior to registration if pre- or perimenopausal (i.e., last menstrual period within one year of registration); both pemetrexed and erlotinib are Class D agent with the potential for teratogenic or abortifacient effects; patients both females and males with reproductive potential (i.e. menopausal for less than 1 year and not surgically sterilized) must practice contraceptive measures throughout the study * Patients taking Warfarin or nonsteroidal anti-inflammatory drugs (NSAIDs) are eligible; patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of Alimta; if the patient is taking other cytochrome P450 3A4 (CYP3A4) inducers or inhibitors, they must be discontinued at least one week prior to starting erlotinib * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had immunotherapy, hormone, 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 who have received pemetrexed or an EGFR TKI (such as erlotinib, gefitinib, or a second generation anti-EGFR TKI) for their metastatic disease should be excluded from this clinical trial; other molecularly targeted agent, including monoclonal antibody or vaccine against EGFR or angiogenesis inhibitor, is allowed * Patients may not be receiving any other investigational or commercial agents or therapies other than those described below with the intent to treat the patient's malignancy * Patients with uncontrolled brain metastases should be excluded from this clinical trial because of their poor prognosis * History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or pemetrexed or other agents used in the study * Patients with 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, are ineligible * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (such as bacteremia or active hepatitis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib or pemetrexed or other agents administered during the study; appropriate studies will be undertake in patients receiving combination anti-retroviral therapy when indicated

Study Objectives The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases. Conditions: Pulmonary Diseases, Intraoperative Complications Intervention / Treatment: DRUG: Fibrinogen (human) + thrombin (human) (TachoSil) Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.

Study Objectives The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: Radium-223 dichloride (Xofigo, BAY88-8223), DRUG: Placebo (saline), DRUG: Exemestane, DRUG: Everolimus Location: Israel, Norway, Germany, Japan, Korea, Republic of, Italy, Spain, Switzerland, United Kingdom, United States, Belgium, Singapore, Taiwan, Hong Kong, Austria, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy. * Documentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available. * Documentation of menopausal status: postmenopausal subjects or pre-menopausal subjects with ovarian radiation or concomitant therapy with a luteinizing hormone-releasing hormone (LH-RH) agonist/antagonist are eligible. * Subjects with bone dominant disease with at least 2 skeletal metastases identified at baseline by bone scintigraphy and confirmed by computed tomography (CT)/magnetic resonance imaging (MRI). * Subjects must have received at least one line of hormonal therapy in the metastatic setting. * Subjects who are eligible as per the Investigator's assessment and according to the local label for treatment with exemestane and everolimus as a second line or greater of hormone therapy in a metastatic setting. * Subjects must have experienced recurrent/progressive disease following treatment with a non-steroidal aromatase inhibitor (letrozole or anastrozole) in an adjuvant or metastatic setting * Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: need for external beam radiotherapy (EBRT) to bone pain, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted. * Subjects must be on therapy with bisphosphonates or denosumab for at least 1 month before start of study treatment. * Adequate hematological, liver and kidney function. Exclusion Criteria: * Subjects with Inflammatory breast cancer. * Patients with immediately life-threatening visceral disease for whom chemotherapy is preferred treatment option. * Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable provided it was administered at least 1 year prior to study entry. * Subjects who received prior treatment or are already receiving everolimus treatment prior to study entry are not eligible. * Subjects with known or history of brain metastases or leptomeningeal disease: subjects with neurological symptoms must undergo a contrast CT scan or MRI of the brain within 28 days prior to randomization to exclude active brain metastasis. Imaging of the central nervous system (CNS) is otherwise not required.

Study Objectives This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the vascular disrupting agent NPI-2358 in patients with refractory solid tumors or lymphoma. The formation of new blood vessels (angiogenesis) is an important component of tumor growth and vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. NPI-2358 has also been seen to directly affect tumor cells. Conditions: Cancer Intervention / Treatment: DRUG: NPI-2358 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: * ECOG performance status ≤ 2 * Pathologically or histologically confirmed solid tumor malignancy * Patients must not be candidates for regimens known to provide clinical benefit. * All adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v. 3.0) Grade ≤ 2, except for neurological toxicity that must have resolved to Grade ≤ 1. * Adequate bone marrow reserve, hepatic and renal function * Signed informed consent Exclusion Criteria: * Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 21 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 6 weeks before first study drug administration. Radiotherapy within 4 weeks (some types of radiation therapy are excluded regardless of interval since treatment). * Significant cardiac history or findings * Underlying conditions or medications associated with bleeding diathesis * Disorders associated with significant vascular pathology * Lung cancer with central chest tumors * Prior treatment with vascular disruptive agents * Seizure disorder requiring anticonvulsant therapy; prior transient ischemic attack or cerebrovascular accident * Brain metastases * Severe chronic obstructive pulmonary disease (COPD) with hypoxemia * Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy * Known infection with human immunodeficiency virus (HIV), active hepatitis A, B, or C * Patients with a prior hypersensitivity reaction to any product containing Solutol and/or propylene glycol * Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Female patients with childbearing potential must have a negative serum pregnancy test. Male patients must be surgically sterile or agree to use an acceptable method of contraception. * Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix

Study Objectives Primary Objective: To evaluate the pharmacokinetics (PK) of isatuximab. Secondary Objectives: * To evaluate the safety and tolerability of isatuximab. * To assess the preliminary antitumor effect of isatuximab. * To evaluate the immunogenicity of isatuximab. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Isatuximab SAR650984 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Known diagnosis of symptomatic multiple myeloma. * At least 2 prior lines of therapies which must include treatment with at least 1 of an immunomodulatory drug (IMiD) or a proteasome inhibitor (PI). The patients must have received an IMiD or a PI for ≥2 cycles or ≥2 months of treatment. * Patients must have been responsive to at least 1 prior line of therapy (minimal response or better). * Refractory to the most recently received IMiD or PI included therapy (ie, patients must have progressed during or within 60 days of completion of treatment with IMiD or PI). For patients who have received more than 1 type of IMiD or PI, their disease must be refractory to the most recent one. * Measurable disease defined as at least 1 of the following: * Serum M-protein ≥0.5 g/dL (≥5 g/L); * Urine M-protein ≥200 mg/24 hours. * Written informed consent. Exclusion criteria: * <18 years old. * Eastern Cooperative Oncology Group (ECOG) performance status >2. * Life expectancy of less than 3 months. * Pretreated with any anticluster of differentiation (CD) 38 agent. * Concurrent plasma cell leukemia. * Known amyloidosis. * Disease measurable only by serum free light chain (FLC) analysis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors. Conditions: Advanced Cancer Intervention / Treatment: DRUG: CS1001 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected. * ECOG performance status of 0 or 1. * Subjects must have at least one measurable lesion. * Patients with life expectancy ≥ 3 months. * Subject must have adequate organ function. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for six months after last study drug administration. Exclusion Criteria: * Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. * Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded. * Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment. * Known history of HIV infection. * Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive. * Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma. * Known history of alcoholism or drugs abuse. For more information regarding trial participation, please contact at [email protected]

Study Objectives This study aims to investigate the treatment of previously untreated stage I-II Extranodal NK/T Cell Lymphoma with sintilimab, peg-aspargase and anlotinib, "sandwich" with radiotherapy. The primary endpoint is the complete response rate (CRR) at the end of the treatment, and the second endpoints are CRR after two cycles of the combined regimen (CRR2), overall response rate (ORR) at the end of the treatment, survival time (OS and PFS) and toxicities. Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, Early Stage, Anlotinib, Peg-aspargase, Sintilimab, Phase Two, Open, Radiotherapy Intervention / Treatment: DRUG: Sintilimab Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed NK/T cell lymphoma; * Male or female: ≥18 and ≤70 years old; * Eastern Cooperative Oncology Group (ECOG) status 0-3; * Estimated survival time > 3 months; * No previous anti-tumor therapy including radiotherapy, chemotherapy, targeted therapy or stem cell transplantation; * At least one evaluable or measurable lesion complying with Lugano 2014 Standard (evaluable lesion: the examination show increased uptake of lymph nodes or extranodal areas (higher than that of the liver) by 18F-Fluorodeoxyglucose/ Positron Emission Tomography (18FDG/PET) and the PET and/or Computed Tomography (CT) features coincide with lymphoma characteristics; measurable lesion: sarcoidal lesions were longer than 15 mm or extranodal lesions were longer than 10 mm, and accompanied by increased 18FDG uptake). Increased liver diffuse 18FDG uptake without measurable lesions should be excluded. * The main organs function well, namely, the following requirements were met one week before admission: Blood routine WBC ≥ 3.5×109/L, Hb ≥ 100g/L and PLT ≥ 90×109/L; Heart and liver function were normal (total bilirubin ≤1.5×ULN, ALT and AST ≤ 2.5×ULN), renal function was normal (serum creatinine ≤1.5×upper limitation of normal (ULN)), and without abnormal coagulation function. * Fertile patients must undergo pregnancy tests (serum or urine) within 14 days prior to study enrollment and the results are negative, and they are willing to use effective contraception during the trial; * The imaging evaluation was Ann Arbor stage I/II. * Voluntary participation and signed the informed consent, good compliance, with follow-up. Exclusion Criteria: * Patients allergic of any of drug in this regimen; * Pregnant or lactating women * Participated in other clinical trials within the 4 weeks prior to enrollment; * Previous treatments with small molecule tyrosine kinase inhibitors, including familinib,sorafenib, sunitinib, regofinib, anlotinib, furquintinib, etc. * Imaging showed tumors have involved important blood vessels (e.g. enveloping internal carotid artery/vein), or by investigators determine highly likely during the follow-up study and cause fatal hemorrhage * History of severe hemorrhage, or any bleeding events with a severe grade of 3 or more in CTCAE 4.0 within 4 weeks prior to enrollment * Blood pressure unable to be controlled ideally with single antihypertensive drug therapy (Systolic blood pressure > 140 mmHg, Diastolic Blood Pressure > 90 mmHg); Clinically significant cardiovascular disease (e.g. activity) including history of CVA (within 6 months), myocardial infarction (within 6 months), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure; serious cardiac arrhythmia beyond drug control or potentially affecting experimental therapy. * Active ulcer, intestinal perforation or intestinal obstruction; * History of gastrointestinal perforation within 28 days prior to enrollment; * Various factors affecting the oral administration and absorption of drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); * Abnormal coagulation or bleeding tendency (It must be satisfied that INR is under normal range without anticoagulant within 14 days prior to signing informed consent); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; on the premise that the international standardized ratio of prothrombin time (INR) is less than 1.5, small doses of warfarin (1 mg po, qd) or aspirin (no more than 100 mg qd) are allowed for preventive purposes. * Arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to precancerous chemotherapy is excluded if it has been cured judged by the researchers) and pulmonary embolism. * Renal insufficiency: routine urine tests indicate that urine protein is more than + +, or 24 hours urine protein is more than 1.0 g. * Suffered major surgery within 28 days prior to enrollment; * Received strong inhibitors of CYP3A4 within a week or strong inducers of CYP3A4 within 2 weeks prior to enrollment. * Long-term non-healing wound or incomplete-healing fracture. * Symptomatic brain metastases (confirmed or suspected); * Severe or uncontrolled infections * History of psychotropic drug abuse and unable to get rid of or with mental disorders; * History of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history; * Previous and present objective evidences including history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severe impairment of pulmonary function. * History of other malignancy within the last 5 years prior to enrollment, except for cured basal cell carcinoma of skin, cervix in situ carcinoma and superficial bladder cancer;Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.

Study Objectives Compatibility of the topotecan therapy in combination with carboplatin. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Hycamtin Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age >= 18 years * patient with ovarian cancer after primary therapy * bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl * renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min * liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range * ECOG <= 2 * Intention of regular follow-up visits for the duration of the study * written informed consent Exclusion Criteria: * any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol * ECOG > 2 * patients with radiotherapy within the last 4 weeks

Study Objectives The purpose of this interventional study is to determine the feasibility to combine standard chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy (Tocilizumab and Peg-Intron). This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoclonal antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor prognosis and chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian cancer, therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may represent a promising strategy to both abolish drug resistance and amplify host immunity in patients with recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance immunogenic cell death and restore local normal DC maturation. In addition, the use of interferon-alpha (Peg-Intron) allows the full maturation of DC, thereby enhancing the anti-tumor response. Conditions: Recurrent Ovarian Cancer Intervention / Treatment: DRUG: tocilizumab and interferon alpha 2-b, DRUG: Carboplatin and Caelyx or doxorubicin Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically proven epithelial ovarian cancer * Progression of disease or relapse after previous therapy with platinum * Measurable disease (RECIST 1.1) or elevated CA125 > 2 times the upper normal limit (UNL) within 3 months and confirmed * Age ≥18 years * WHO performance status 0-2 * Adequate bone marrow function: WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l * Adequate liver function: bilirubin ≤1.5 x UNL range, ALAT and/or ASAT * 2.5 x UNL (<5x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL * Adequate renal function: the calculated creatinine clearance should be * 50 mL/min * Survival expectation > 3 months * Patients must be accessible for treatment and follow-up * Written informed consent according to the local Ethics Committee requirements Exclusion Criteria: * Chemotherapy within past 3 months * Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias * Known hypersensitivity reaction to any of the components of the treatment * Pregnancy or lactating * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent * Infection with tuberculosis and hepatitis B or C

Study Objectives Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion. Conditions: Oral Cancer, Head and Neck Cancer, Free Flap, Hypotension Intervention / Treatment: DRUG: Epinephrine, DRUG: Norepinephrine, DRUG: Dobutamine, DRUG: Dopexamine Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit. Exclusion Criteria: * Pregnancy * Weight >100kg * Contraindications to pressor infusions * Overnight ventilation not indicated

Study Objectives The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy Conditions: Ovarian Cancer Intervention / Treatment: DRUG: AZD2281, DRUG: matching placebo Location: Israel, Estonia, Canada, Germany, Netherlands, Spain, Romania, Ukraine, United Kingdom, United States, Belgium, Australia, Austria, Czechia, Russian Federation, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer. * Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen. * For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy. * Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen. Exclusion Criteria: * Previous treatment with PARP inhibitors including AZD2281 * Patients with low grade ovarian carcinoma. * Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study * Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).

Study Objectives To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment. Conditions: Breast Neoplasms, Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: SCH 727965, DRUG: Capecitabine, DRUG: Erlotinib Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >=18 years, either sex, any race. * Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease. * BREAST CANCER: * participant must have previously received both a taxane and an anthracycline (unless anthracycline therapy is contraindicated) in the adjuvant and/or metastatic setting, * participant with HER2-positive disease must have progressed after trastuzumab and concomitant or subsequent lapatinib, * participant must have received at least one, but no more than two prior regimens for recurrent or metastatic disease (endocrine and biologic therapies do not count as chemotherapeutic regimens). * NSCLC: at least one, but no more than two prior chemotherapeutic regimens for advanced disease. * Measurable disease by the RECIST. * Eastern Cooperative Oncology Group performance status of 0, 1, or 2. * Adequate hematologic, renal, and hepatic organ function and laboratory parameters. * Ability to swallow tablets. Exclusion Criteria: * Known brain metastases. For NSCLC only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization. * History of previous radiation therapy to >25% of total bone marrow. * Known HIV infection. * Known active hepatitis B or hepatitis C. * Previous treatment with SCH 727965 or other cyclin-dependent-kinase inhibitors. * BREAST CANCER: * known dihydropyrimidine dehydrogenase deficiency, * previous treatment with capecitabine. * NSCLC: previous treatment with erlotinib.

Study Objectives RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer. Conditions: Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelofibrosis, MDS, Refractory Anemia, Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Non-Hodgkin's Lymphoma, Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndromes Intervention / Treatment: BIOLOGICAL: filgrastim, DRUG: cyclophosphamide, DRUG: cyclosporine, DRUG: fludarabine phosphate, DRUG: mycophenolate mofetil, PROCEDURE: umbilical cord blood transplantation, RADIATION: total-body irradiation 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: * Acute myeloid leukemia (AML): high risk CR1 (as evidenced by preceding myelodysplastic syndrome \[MDS\], high risk cytogenetics, ≥ 2 cycles to obtain complete remission \[CR\], erythroblastic or megakaryocytic leukemia; CR2+. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%. * Very high risk pediatric patients with AML. Patients <21 years, however, are eligible with (M2 marrow) with < or = 25% blasts in marrow after having failed one or more cycles of chemotherapy. This group of patients will be analyzed separately. * Acute lymphocytic leukemia (ALL): high risk CR1 \[t(9;22), t (1:19), t(4;11) or other MLL rearrangements\] hypodiploidy, or IKZF1 abnormalities), DNA index < 0.81, > 1 cycle to obtain CR or presence minimal residual disease (MRD). Patients in CR2+ are eligible. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%. * Very high risk pediatric patients with ALL. patients <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission * Chronic myelogenous leukemia (CML) excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate. * Plasma Cell leukemia after initial therapy, who achieved at least a partial remission * Advanced myelofibrosis * Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology. * Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant. * Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy in CR1+ or PR1+. * Large cell NHL > CR2/> PR2. Patients in CR2/PR2 with initial short remission (<6 months) are eligible. * Lymphoblastic lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year. * Multiple myeloma beyond PR2. Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy. * Recipients must have a Karnofsky score (adults) ≥ 80 % or Lansky score ≥ 50% (pediatrics), and proper organ function. Exclusion Criteria * Active infection at time of transplantation * History of human immunodeficiency virus (HIV) infection * Pregnant or breast feeding. * Chemotherapy refractory large cell and high grade NHL * If < or = 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant * Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation. * Patients who have received Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy.

Study Objectives This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity. Conditions: Breast Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Capecitabine, DRUG: Pertuzumab, DRUG: Trastuzumab Location: Hungary, Canada, Austria, Czechia, France, Poland, Thailand, Italy, Netherlands, Peru, United Kingdom, Russian Federation, Croatia, Estonia, Spain, Brazil, Belgium, Mexico, Germany, Korea, Republic of, Romania, Hong Kong, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adult female patients >=18 years of age * Metastatic HER2 positive breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen) * Prior treatment with taxane-containing regimen * Left ventricular ejection fraction (LVEF) >=50 percent * For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment Exclusion Criteria: * Prior treatment with pertuzumab or capecitabine * Concurrent treatment with other experimental drug * Concurrent immunotherapy or anticancer hormonal therapy * Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease) * Central nervous system (CNS) metastases, which are not well controlled * History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 * History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment * History of myocardial infarction within 6 months prior to randomization * History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab * History of another cancer which could affect compliance or result interpretation * Inadequate organ function * Pregnant or breastfeeding women * life expectancy < 12 weeks

Study Objectives This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products. Conditions: Breast Cancer Intervention / Treatment: DRUG: 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, DRUG: Perjeta (EU origin) 420 mg in 14 mL Injection, DRUG: Perjeta (US origin) 420 mg in 14 mL Injection Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * aged 18 to 55 years * overtly healthy as determined by medical evaluation * Body weight of at least 50 kg and not higher than 105 kg at screening * BMI above/equal to 18.0 and below/equal to 30.0 kg/m2 at screening * Male * Agrees to the following during the treatment period and until 3 months after administration: * Be and remain abstinent from heterosexual intercourse OR agree to use a male condom and female partners of childbearing potential must use an additional highly effective contraceptive method * Abstain from donating sperm. * Signed informed consent * Valid COVID-19 immunization status as per current regulations Exclusion Criteria: * History or evidence of any clinically relevant disease, as judged by the investigator * Any medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this trial in the opinion of the investigator * Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the IMP will not be normal * Known or suspected hypersensitivity to the IMPs (active substances, or excipients of the preparations) * Known severe allergies e.g., allergies to more than 3 allergens * Relevant diseases within the last 4 weeks before IMP administration * Febrile illness within 2 weeks before IMP administration. * History of known or suspected malignant tumors * Known or suspected disorder of the liver * Use of systemic/topical medicines/substances which oppose the trial objectives, or which might influence them within 4 weeks before IMP administration * Regular use of therapeutic or recreational drugs or supplements * Use of any herbal products or St. John's wort from 4 weeks before IMP administration * Prior treatment with pertuzumab * Smoking * History of alcohol or drug abuse * Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form * Intake of alcohol containing food and beverages from 48 h prior to admission to the ward * Regular daily consumption of more than 1 L of methylxanthine-containing beverages * Excluded physical therapies that might alter the PK or safety results of the trial from 7 days before IMP administration until follow-up * Strenuous physical exercise or sauna visit with 72 h before admission to the ward * Donation of more than 100 mL of whole blood or plasma within 4 weeks or approximately 500 mL whole blood within 3 months before IMP administration * Plasmapheresis within 3 months before IMP administration * Previous or concomitant participation in another clinical trial with IMP(s) * Clinically relevant findings in the ECG * LVEF below 55% * Systolic blood pressure below 100 mmHg or above 140 mmHg * Diastolic blood pressure below 50 mmHg or above 90 mmHg * Heart rate below 50 beats/ min or above 90 beats/min * Clinically relevant findings in the physical examination that may affect the objectives of the trial, or the safety of the participant * Poor venous access * Clinically relevant deviations of the screened safety laboratory parameters * Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase, or total bilirubin above 1.2 upper limit of normal * Thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) level outside the normal reference range * Positive results for hepatitis B virus surface antigen, hepatitis C virus antibodies, human immune deficiency virus antibodies, and human immune deficiency virus antigen * Positive urine drug test * Positive alcohol test * Positive cotinine test * Any criteria which, in the opinion of the investigator, preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety * Close affiliation with the investigational site * Vulnerable participants who are e.g., institutionalized due to regulatory or juridical order dependent on sponsor, site, or investigator or not able to consent, respectively. * History of COVID-19 within 2 months prior to screening * Long COVID-19 syndrome or other clinically relevant COVID-19 related symptoms or sequelae * Positive SARS-CoV-2 viral ribonucleic acid (RNA) test at admission * No SARS-CoV-2 vaccinations should be booked within 14 days before IMP administration and until last trial visit.

Study Objectives This phase II trial studies how well dalantercept works in treating patients with endometrial cancer that has come back or is persistent. Dalantercept may stop the growth of endometrial cancer by blocking blood flow to the tumor. Conditions: Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Mucinous Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Squamous Cell Carcinoma, Endometrial Transitional Cell Carcinoma, Endometrial Undifferentiated Carcinoma, Recurrent Uterine Corpus Carcinoma Intervention / Treatment: BIOLOGICAL: Dalantercept, 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 endometrial carcinoma; histologic confirmation of the original primary tumor is required * Patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma * All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI * Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1; 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 Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol or rare tumor 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 urinary tract infection \[UTI\]) * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration * Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration; any investigational drug must be discontinued at least 30 days prior to registration * Any prior radiation therapy must be discontinued at least four weeks prior to registration * At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay in treatment for minor procedures (e.g., central venous access catheter placement) * Prior therapy * Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen * Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease * Patients must have NOT received any non-cytotoxic (biologic or targeted) agent(s) for management of recurrent or persistent disease; prior non-cytotoxic (biologic or targeted) agent(s) is allowed as part of initial treatment; prior hormonal therapy is allowed, but must be discontinued at least one week prior to registration * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL * Platelets greater than or equal to 100,000/mcL * Hemoglobin greater than or equal to 9 g/dL * Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN) * Sodium greater than or equal to 130 mEq/L (Common Terminology Criteria for Adverse Events \[CTCAE\] v. 4, grade 0 or 1) * Urine protein should be screened by urinalysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be < 1,000 mg (< 1.0 g/24 hrs) for patient enrollment * Bilirubin less than or equal to 1.5 times ULN * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 times ULN * Alkaline phosphatase less than or equal to 3 times ULN * Albumin greater than or equal to 3 (CTCAE v. 4, grade 0 or 1) * Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 times ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) * Partial thromboplastin time (PTT) less than or equal to 1.5 times ULN * Left ventricular ejection fraction (LVEF) greater than 50% (measured by echocardiogram or MUGA \[multi-gated acquisition\] scan) * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients must meet pre-entry requirements * Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception Exclusion Criteria: * Patients who have had prior therapy with dalantercept or other inhibitor of the ALK1 pathway * 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 three 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 endometrial cancer within the last three 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 who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease * Patients with history or evidence upon physical exam of central nervous system disease (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases or leptomeningeal disease * Serious or non-healing wound, ulcer, or bone fracture * History of abdominal fistula or anastomotic leak, gastrointestinal perforation, or intra-abdominal abscess within 6 months of registration * Patients requiring parenteral hydration or parenteral/total parenteral nutrition * No patients with: * Active bleeding (e.g., active hemoptysis, defined as bright red blood of greater than or equal to ½ teaspoon \[2.5 ml\] in any 24-hour period) within 2 weeks prior to registration or gastrointestinal bleeding within 3 months prior to registration * Hereditary hemorrhagic telangiectasia (HHT) * Platelet function abnormality * Autoimmune or hereditary hemolysis * Coagulopathy, or * Tumor involving major vessels (defined as any lesion invading or abutting the wall \[i.e., no fat plane evident\] of major blood vessels as assessed by CT or MRI) * Patients receiving treatment with full-dose aspirin (325 mg oral daily), clopidogrel (Plavix), or dabigatran (Pradaxa) * Patients with peripheral edema greater than or equal to grade 1 within 4 weeks of registration * No patients with clinically significant cardiovascular disease: * Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications * Evidence of hypertrophic cardiomyopathy * New York Heart Association (NYHA) class II or greater congestive heart failure (CHF) * Any of the following within 6 months prior to study registration: * Bypass surgery * Stent placement * Myocardial infarction * Acute coronary syndrome/unstable angina * Hospitalization for congestive heart failure (CHF) * Serious cardiac arrhythmia requiring medication; this does not include asymptomatic atrial fibrillation with controlled ventricular rate * Prolonged QTc interval > 450 ms * Prior anthracycline cumulative dose > 450 mg/m\^2 * Patients who are pregnant or nursing * History of syndrome of inappropriate antidiuretic hormone secretion (SIADH) * Patients who have undergone a therapeutic paracentesis within 4 weeks of registration * Known history of positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), or HBV core antibody, or human immunodeficiency virus (HIV) antibody results * History of severe (National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v.4.0 >= grade 3) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline) in the investigational agent * Clinically significant active pulmonary risk including pulmonary hypertension, pulmonary embolism, or history of pulmonary edema

Study Objectives Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study, the investigators propose an evaluation of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer. Conditions: Metastatic Breast Cancer Intervention / Treatment: DRUG: Amrubicin 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: * Females >=18 years of age. * Histologic diagnosis of HER2-negative breast cancer. HER-2 negativity must be confirmed by one of the following: * FISH-negative (FISH ratio <2.2), or * IHC 0-1+, or * IHC 2-3+ AND FISH-negative (FISH ratio <2.2) * Evidence of metastatic or locally advanced, inoperable breast cancer. * Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens. * Patients with prior anthracycline therapy are eligible, provided their previous anthracycline was ≥6 months prior to study entry. * Measurable disease per RECIST criteria version 1.1 * Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA). * Patients must have QTc interval of <=450 msec. * No intercurrent significant medical conditions or cardiac illness. * Patients must be >=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2. * Adequate organ function including the following: * ANC >=1500 cells/mL * Platelet count >=100,000 cells/mL * Hemoglobin >=9 g/dL * Total bilirubin <=1.5 x ULN; AST/ALT <=2.5 x ULN, (except if due to hepatic metastases, then <=5 x ULN) * Serum creatinine <1.5 x ULN * Women of childbearing potential must have a negative serum or urine pregnancy test performed <=7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. * Patients must be accessible for treatment and follow-up. * Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry. * Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable. Additionally, the patient's INR must be adequate if the patient is receiving treatment with coumadin. * Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient's enrollment in this study. Exclusion Criteria: * Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy. * Prior treatment with >=3 regimens of cytotoxic therapy in the advanced disease setting. (Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient's enrollment into this study). * Major surgery or systemic therapy <=3 weeks of study treatment. * Prior high-dose chemotherapy requiring hematopoietic stem cell support. * Prior radiation therapy to >25% of the bone marrow. * Uncontrolled brain metastases. Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at >=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued. * Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis. * Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ \[DCIS\], or lobular carcinoma in situ \[LCIS\]). * Any of the following <=12 months prior to starting study treatment: * myocardial infarction; * severe unstable angina; * congestive heart failure; * ongoing cardiac dysrhythmia. * Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia. * Patients with previous allergy or hypersensitivity to anthracyclines. * Patients who have had a ≥10% drop in LVEF on previous anthracycline therapy. * Palliative radiotherapy to areas of metastatic breast cancer must have been completed >7 days prior to the first dose of study treatment. The exception is radiotherapy for brain metastases, which must be completed >=21 days prior to study treatment. (Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion). * Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. * History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications. * Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study. * Use of any non-approved or investigational agent <=30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.

Study Objectives Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for years. However, objective evidence of the effect of SGB was still lack. The investigators conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of electrocochleography (ECoG). Conditions: Vertigo, Meniere Disease Intervention / Treatment: PROCEDURE: stellate ganglion block, DRUG: 0.25mg, fludiazine, DRUG: 25mg cephadol@ (diphenidol), DRUG: 200mg kentons@ (tocopherol nicotinate). Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * patients diagnosed with unilateral Meniere's disease, according to the criteria of the American Academy of Otolaryngology-Head and Neck Surgery, AAO-HNS (1995) Exclusion Criteria: * patients with coagulopathy, * arrhythmia, * myocardial ischemia, * glaucoma, * pregnant, * chronic otitis media or externa, and * past history of middle or inner ear surgery were excluded.

Study Objectives The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to stimulate an immune response against the cancer. Conditions: Squamous Cell Carcinoma of the Oral Cavity Intervention / Treatment: BIOLOGICAL: IRX-2, DRUG: Cyclophosphamide, DRUG: Indomethacin, DIETARY_SUPPLEMENT: Zinc-containing multivitamin, DRUG: Omeprazole Location: United States, Brazil, United Kingdom, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pathologically confirmed (histology or cytology) clinical Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip). Subjects must be staged using AJCC Cancer Staging Manual Edition 7.0 (appendices 1 and 2). * Disease surgically resectable with curative intent * Hematological function: hemoglobin >9 g/dL; lymphocyte count >0.50 x 109/L; neutrophil count >1.5 x 109/L; platelet count >100 x 109/L * Hepatic function: serum albumin >3.0 g/dL; aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <3x the upper limits of normal (ULN); alkaline phosphatase <2x the ULN * Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN * Calculated creatinine clearance > 50 mL/minute (Appendix 4) * At least 18 years of age * Willing and able to give informed consent and adhere to protocol therapy * Karnofsky performance status (KPS) >=70% * Females of childbearing potential (not surgically sterile or less than 12 months post-menopausal) must be able and willing to use a highly effective form of pregnancy prevention from the time of screening, during the study and 30 days after last dose of study regimen. Males with a partner of childbearing potential must use condoms with spermicide from the date of screening to 30 days after their last dose of study regimen * Negative urine/serum pregnancy test, if applicable Exclusion Criteria: * Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer. * Any medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately * Live vaccines should ideally not be administered to any patients undergoing treatment with chemotherapy or immunotherapy, but if need be, they should be administered >4 months prior to the initiation of treatment or >4 months after the completion of all treatment * Inactivated vaccines should precede the initiation of any study regimen and/or standard adjuvant therapy by at least 2 weeks, but preferably 4 weeks or longer * Clinical status of either subject or tumor such that administration of 21 day neoadjuvant IRX-2 Regimen 1 or 2 before surgery would be medically inappropriate * Tumor of the oropharynx * Tumor involvement of the following sites or any of these signs or symptoms likely to be associated with T4b cancer: * involvement of pterygopalatine fossa, maxillary sinus, or facial skin;. * gross extension of tumor to the skull base; * pterygoid plate erosion; * sphenoid bone or foramen ovale involvement; * direct extension to involve prevertebral fascia; * extension to superior nasopharynx or Eustachian tube; * direct extension into the neck with involvement of the deep neck musculature (neck node fixation); * suspected invasion (encasement) of the common or internal carotid arteries. Encasement will be assessed radiographically and will be defined as tumor surrounding the carotid artery 270º or greater; * direct extension of neck disease to involve the external skin; * direct extension to mediastinal structures; * regional metastases to the supraclavicular neck (low level IVB or VB) * Any investigational agent within the previous 30 days. * Daily administration of systemic immunosuppressive therapy or corticosteroids (except in physiological doses for hormone deficiency) during the previous 30 days. * Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral anticoagulation or other platelet function inhibitors, that can not, in the documented opinion of the investigator, safely be interrupted from at least 2 days prior to the initiation of the study regimen until after surgical resection of the tumor. * Symptomatic cardiopulmonary disease (including congestive heart failure and hypertension), coronary artery disease, serious arrhythmia or chronic lung disease. Patients with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for surgical treatment of their tumor need not be excluded * Myocardial infarction within the last 3 months * Distant metastases (M1 disease). * Known infection with hepatitis B, hepatitis C, or HIV. * Signs or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection). * Clinically significant gastritis or peptic ulcer disease that would contraindicate the use of indomethacin. * Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months. * Allergy to ciprofloxacin (or other quinolones), acetylsalicylic acid, or indomethacin. * Previous diagnosis of invasive cancer from which the individual is NOT disease-free AND that has required treatment within the past 5 years, except for superficial skin, cervical cancer in-situ, well-differentiated thyroid or early stage prostate or bladder cancer (i.e., treatment with curative intent and long term disease-free expectations). * Prior axillary dissection. * Breastfeeding women.

Study Objectives There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerated dose of the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients with FLT3-ITD and -D835 mutated acute myeloid leukemia (AML) or FLT3-mutated high-risk myelodysplastic syndrome (MDS). The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control the disease. The safety of the drug combination will also be studied in both parts of this study. This is an investigational study. Sorafenib is FDA approved and commercially available to treat hepatocellular cancer. Selinexor is not FDA approved or commercially available. It is currently being used for research purposes only. The combination of selinexor and sorafenib to treat FLT3-mutated AML and high-risk MDS is investigational. The study doctor can explain how the study drugs are designed to work. Up to 52 participants will take part in this study. All will be enrolled at MD Anderson. Conditions: Leukemia, Acute Myeloid Leukemia Intervention / Treatment: DRUG: Selinexor, DRUG: Sorafenib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * FLT3-ITD and/or FLT3-D835 mutated patients 18 years of age or older with relapsed/ refractory AML (any number of relapses) including patients who may have been previously exposed to one or more FLT3-inhibitor therapies will be eligible for the phase I portion of this study. * Phase II FLT3-ITD and/or FLT3-D835 mutated relapsed/refractory patients: Patients should have a diagnosis of AML (de novo or transformed from hematologic malignancies). Patients with high-risk myelodysplastic syndrome (MDS) (defined as having >= 10% blasts in the bone marrow) or patients with Chronic Myelomonocytic Leukemia (CMML) (having >= 10% blasts in the bone marrow) may also be eligible after discussion with Principal Investigator (PI). The patients should have one of the following features: 1. Patients with AML should have failed any prior induction therapy or have relapsed after prior therapy. 2. Patients with high-risk MDS or high-risk CMML should have failed any prior therapy for the MDS or CMML. 3. Patients with MDS or CMML who received therapy for the MDS or CMML and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The World Health Organization (WHO) classification will be used for AML. * Patients must be eligible for one of two cohorts: Cohort 1 (FLT3 and/or FLT3-D835 inhibitor failure cohort) in FLT3-ITD and/or FLT3-D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens (SCT or stem cell therapy for patients who previously underwent SCT/stem cell therapy in remission will not be considered a salvage regimen) and have previously been exposed at least one prior FLT3 inhibitor. Cohort 2 (FLT3 inhibitor naive cohort) in FLT3-ITD and/or FLT3-D835 mutated relapsed/refractory who have failed therapy with up to two prior salvage regimens (SCT or stem cell therapy for patients who previously underwent SCT/stem cell therapy in remission will not be considered a salvage regimen) with no prior exposure to any FLT3 inhibitor. * Age >=18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status <=2 * Patients should have estimated life expectancy of >3 months at study entry * Adequate hepatic (serum total bilirubin <= 2.0 x upper limit normal (ULN) (or <= 3.0 x ULN if deemed to be elevated due to leukemia), alanine aminotransferase and/or aspartate transaminase <= 3.0 x ULN (or <= 5.0 x ULN if deemed to be elevated due to leukemia), and renal function (creatinine <= 2.0 mg/dL). * Patients must provide written informed consent. * In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of selinexor and sorafenib administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for cytotoxic/noncytotoxic agents. The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled Central Nervous System (CNS) leukemia at the discretion of the PI and with the agreement of the Sponsor. Controlled CNS leukemia is defined by the absence of active clinical signs of CNS disease and no evidence of CNS leukemia on the most recent 2 simultaneous CSF evaluations. (2) Use of one dose of cytarabine (up to 2 g/m2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. These medications will be recorded in the case-report form. * Baseline ejection fraction must be >= 40%. * Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment. * Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment. Adequate methods of contraception include: Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment * (Continued from Criteria 12) Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient Combination of any of the two following (a+b or a+c or b+c) Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository * (Continued from Criteria 13) In case of use of oral contraception, women should have been stable on the same pill before taking study treatment. Note: Oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case 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. Exclusion Criteria: * Patients with known allergy or hypersensitivity to selinexor, sorafenib or any of its components. * Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness, which could place him/her at unacceptable risk. * Patients who have had any major surgical procedure within 14 days of Day 1. * Patients currently receiving any other standard or investigational therapy for the treatment of AML. * Patients unwilling or unable to comply with the protocol. * Patients receiving concomitant treatment with strong CYP3A4 inhibitors, unless such drugs are considered critical for the well being of the patient and not adequate alternatives are available. Strong CYP3A4 inhibitors include the following medications: itraconazole, ketoconazole, miconazole, voriconazole; amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir; ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, telithromycin. * Patients with any severe gastrointestinal or metabolic condition that could interfere with absorption of oral medications. * Patients who are in blast transformation of chronic myeloid leukemia (CML). Prior MDS or CMML is acceptable. * Patient has a concurrent active malignancy under treatment. * Unstable cardiovascular function: * Symptomatic ischemia, or * Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or * Congestive heart failure (CHF) New York Heart Association (NYHA) Class ≥ 3, or * Myocardial infarction (MI) within 3 months. * Left ventricular ejection fraction < 40 %. * Hypertension > 140 mm Hg systolic or > 90 mm Hg diastolic with or without antihypertensive therapy. * Uncontrolled infection at the time of enrollment. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable. * Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen). * Known human immunodeficiency virus (HIV) infection. * Female subjects who are pregnant or breastfeeding. * Acute promyelocytic leukemia. * Any medical condition, which in the investigator's opinion, could compromise the patient's safety.

Study Objectives The purpose of this study is to evaluate the safety and efficacy of the preoperative docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials. Conditions: Pulmonary Neoplasms Intervention / Treatment: DRUG: Preoperative docetaxel-cisplatin combination chemotherapy, DRUG: Preoperative docetaxel monotherapy Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Newly diagnosed, pathologically documented NSCLC * Clinical stages IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0) * Ages: 15-74 years old * ECOG performance status 0 or 1 * Measurable disease * Ample organ function * Signed informed consent Exclusion Criteria: * Invasion to the first rib or more superior chest wall * Metastasis to, or involvement of, mediastinal node * Active concomitant malignancy * Unstable angina, recent myocardial infarction, or heart failure * Uncontrolled diabetes or hypertension * Pregnant or lactating women * Other severe complications * Systemic use of corticosteroids

Study Objectives The objective of this investigation was to evaluate the influence of Butorphanol on postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor. Employing a rigorously designed multicentral, randomized, and placebo-controlled format, patients subjected to microwave ablation were assigned randomly to either Butorphanol (experimental group) or normal saline (control group). Primary outcomes encompassed intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the 6-hour mark (VAS) and comprehensive pain assessment outcomes. Conditions: Visceral Pain, Microwave Ablation, Hepatic Tumor Intervention / Treatment: DRUG: Butorphanol, DRUG: normal saline Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: DOUBLE

Inclusion Criteria: patients performing Microwave Ablation sign the informed consent Exclusion Criteria: Patients with a body mass index > 30 kg/m2 a history of depression opioid dependence poorly controlled hypertension (systolic blood pressure > 180 mmHg) myocardial infarction severe liver disease significant abdominal pain before surgery patients with sensory system or language dysfunctions who could not cooperate to complete the scale pregnant women.

Study Objectives Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by making them more sensitive to the drug. This phase I trial is studying the side effects and best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced hematologic malignancies Conditions: Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia Intervention / Treatment: DRUG: cytarabine, DRUG: triapine, OTHER: laboratory biomarker analysis 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 confirmed diagnosis of 1 of the following hematologic malignancies: * Relapsed or refractory acute myeloid leukemia (AML) * Relapsed or refractory acute lymphoblastic leukemia * Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML * Chronic myeloid leukemia in accelerated or blast phase * Refractory to standard therapy or no standard therapy exists * No known brain metastases * Performance status - CALGB 0-2 * Performance status - Karnofsky 60-100% * No G6PD deficiency * Bilirubin < 2.0 mg/dL (unless due to Gilbert's syndrome) * AST and ALT < 2.5 times upper limit of normal (ULN) * Creatinine < 1.5 times ULN * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No pulmonary disease requiring oxygen * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reactions attributed to compounds of similar chemical or biological composition to study drugs * No neuropathy * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness * No concurrent biologic agents * At least 72 hours since prior hydroxyurea * At least 2 weeks since other prior chemotherapy (6 weeks for mitomycin or nitrosoureas) * No other concurrent chemotherapy * At least 2 weeks since prior radiotherapy * No concurrent radiotherapy * Recovered from all prior therapy * At least 4 weeks since prior investigational agents * No other concurrent investigational therapy * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for HIV-positive patients

Study Objectives This observational study will observe the degree of the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: bortezomib Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma * Patients who can understand and fill out quality of life questionnaires, and who agree to provide information will be included Exclusion Criteria: * Patients who are hypersensitive to the bortezomib or any component of bortezomib or with a history of the hypersensitivity * Patients with severe hepatic impairment * Pregnant women

Study Objectives This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m). Conditions: Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection Intervention / Treatment: PROCEDURE: 3 doses of HPV 16/18 bivalent vaccine, PROCEDURE: 2 doses of HPV 16/18 bivalent vaccine Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Females aged between 9 and 26 years when they receive the first vaccination (9≤age<27); * Participants aged 9-17 years whose legal guardian can provide identity certificate, or representative can provide authorization; * Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations; * Participants aged 9-17 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent; * Able to comply with the requests of the study; * Axillary temperature not higher than 37.0°C; * Nonpregnancy verified by a urine pregnancy test; Exclusion criteria: * Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months; * Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first vaccination, or plan to use during the study period; * Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray); * Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period; * Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment; * Participants had fever (auxiliary temperature ≥38.0 °C) within 3 days prior to vaccination, or any acute disease requiring systematic antibiotics or antiviral therapy within the past 5 days; * Concurrently participating another clinical trial; * Participants who have received HPV vaccines; * Participants with immunodeficiency disease (such as HIV positive), primary disease in vital organs, cancer (or precancerous lesion), or chronic history of immunological disease requiring treatment (including systemic lupus erythematosus), rheumatoid arthritis, asplenia or splenectomy due to any conditions, and other immunological diseases that may impact immune response as considered by investigator), etc.; * Participants with a history of allergy, including severe adverse reactions due to the past vaccination, such as hypersensitivity, urticaria, dyspnea, angioneurotic edema, or abdominal pain; * Participants with asthma, which is unstable in the past 2 years, requiring emergency treatment, hospitalization, or oral or intravenous corticosteroid; * Participants with concurrent severe medical disorders, such as hypertension, heart disease, diabetes mellitus, or hyperthyroidism, etc.; * Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician; * Participants with epilepsy, excluding febrile epilepsy in patients under 2 years old, alcoholic epilepsy 3 years prior to alcohol abstinence, or pure epilepsy requiring no treatment within the past 3 years; * Participants who are not compliant to the study's requirements due to psychological conditions, or those with prior or existing mental disease or bipolar psychosis which are not well controlled within the past 2 years and require taking drugs, or those with suicidal tendency within the past 5 years; * According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

Study Objectives The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in combination with mFOLFOX6. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Tivozanib, DRUG: Bevacizumab, DRUG: mFOLFOX6 Location: Finland, Hungary, Canada, Czech Republic, Italy, Netherlands, Spain, United Kingdom, United States, Belgium, Australia, Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Documented diagnosis of metastatic colorectal cancer * One measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * No prior systemic chemotherapy for advanced colorectal cancer; no fluorouracil containing adjuvant therapy in previous 6 months * Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 Exclusion Criteria: * Any prior Vascular Endothelial Growth Factor (VEGF)-directed therapy or any other agent or investigational agent targeting the VEGF pathway * Primary Central Nervous System (CNS) malignancies or CNS metastases * Hematologic abnormalities: * Hemoglobin < 9.0 g/dL, * Absolute neutrophil count (ANC) < 2000 per mm\^3, * Platelet count < 100,000 per mm\^3, * Prothrombin (PT) or Partial Thromboplastin Time (PTT) > 1.5 X Upper Limit of Normal (ULN) * Serum chemistry abnormalities: * Total bilirubin > 1.5 X ULN, * Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 X ULN, * Alkaline phosphatase > 2.5 X ULN, * Serum albumin < 2.0 g/dL, * Creatinine > 1.5 X ULN, * Proteinuria > 2+ by urine dipstick * Significant cardiovascular disease * Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug * Non-healing wound, bone fracture, or skin ulcer * Inadequate recovery from any prior surgical procedure or major surgical procedure within 8 weeks prior to administration, or anticipation of major surgical procedure during the course of the study * History of significant gastrointestinal (GI) toxicity, diarrhea, or stomatitis within the last 6 weeks * An active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug * Serious/active infection or infection requiring antibiotics * Significant bleeding disorders within 6 months prior to administration of first dose of study drug * Active second primary malignancy, other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer and ductal or lobular carcinoma in situ of the breast. Subject is not considered to have a currently active malignancy if they have completed anti-cancer therapy and have been disease free for > 5 years * History of allergic reactions, or intolerance, attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, history of Grade 3 hypersensitivity to oxaliplatin, history of allergic reaction to folic acid * Female subject is pregnant or lactating * Known history of genetic or acquired immune suppression disease including Human Immunodeficiency Virus (HIV); subjects on immune suppressive therapy for organ transplant * Inability to swallow pills, malabsorption syndrome or gastrointestinal disease, major resection of the stomach or small bowel, or gastric bypass * Uncontrolled neuro-psychiatric disorder or altered mental status * Peripheral neuropathy ≥ Grade 2 * Participating in another interventional protocol

Study Objectives We planned this study to investigate the efficacy and safety of XELOX (capecitabine and oxaliplatin) plus lapatinib treatment in HER2-positive gastric cancer patients with liver metastasis. Conditions: HER2-positive Gastric Cancer Patients With Liver Metastasis Intervention / Treatment: DRUG: Lapatinib 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 proven gastric cancer with metastatic lesion(s) that is (are) unresectable * locally advanced gastric cancer that are NOT resectable * distant metastases limited to abdominal lymph node, liver only :Patients with liver metastasis : Number of liver metastasis between 2 and 5 or maximal diameter should be under 5 cm (2 = liver mets = 5 or maximal diameter = 5cm) No LN metastasis within group 3 and no bulky N2 metastasis Clinically no distant metastasis (lung metastasis, mediastinal LN metastasis, neck LN metastasis, bone metastasis, brain metastasis, and peritoneal seeding in abdominal and pelvis CT; in cases of suspicious peritoneal seeding in imaging without any evidence of ascites and/or peritoneal enhancement will be allowed to enter the study based on investigators' decision) * chemo-naïve (adjuvant treatment will be allowed if the last date of treatment is ≥ 6 months from the study entry date * Age ≥ 18 * ECOG performance 0 - 1 * Adequate organ function (AST and ALT ≤2x upper limit of normal, bilirubin ≤1.5 x upper limit of normal, and creatinine < 1.5x upper limit of normal, platelet > 100,000/ul, absolute neutrophil count ≥ 1,500/ul) * At least one measurable lesion by RECIST 1.1 criteria * HER 2 (+) by HercepTest(IHC 3+ alone, or IHC 2+ with FISH amplification) * Written informed consent Exclusion Criteria: * Prior therapy for metastatic disease * Pregnant or lactating women * Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months * Any comorbidities which are not suitable for general anesthesia and surgical resection * Distant metastases other than liver or abdominal lymph nodes (As outlined in inclusion criteria, and peritoneal seeding in abdominal and pelvis CT; in cases of suspicious peritoneal seeding in imaging without any evidence of ascites and/or peritoneal enhancement will be allowed to enter the study based on investigators' decision) * Known immediate or delayed hypersensitivity reaction to lapatinib ,capecitabine, oxaliplatin or any other platinum compounds, any recipients. 8) Subjects with DPD deficiency 9) Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) 10) Pre-existing hand and foot syndrome and peripheral neuropathy of grade 2 or greater 11) Subjects unsuitable to resection or general anesthesia

Study Objectives To improve progression free survival in high risk patients with resected pancreatic adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of adjuvant therapy. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: oral azacitidine, OTHER: Observation Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Understand and voluntarily sign an informed consent form. * Age greater than or 18 years at the time of signing the informed consent form. * Able to adhere to the study visit schedule and other protocol requirements. * Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R0 (negative margins) or R1 (microscopically positive margins) resection. * Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy. Although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy ± radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria. * Subjects enrolled due to node + disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA 19-9 elevations can enroll any time after adjuvant therapy has completed. * All previous cancer therapy including radiation, chemotherapy, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study * Subjects must either have a CA 19-9 value > the institutional ULN on two separate checks at least 2 weeks apart OR have had an R1 resection margin OR N1 nodal disease regardless of CA 19-9 level * Subjects must be free of visible disease on imaging (CT, PETCT or MRI) evaluating chest, abdomen, and pelvis within 28 days of enrollment on the study. * Life expectancy of greater than 12 weeks * ECOG performance status of less than or equal to 1 at study entry * Subjects must have normal organ and marrow function * Free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast. * Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC-486 or nab-paclitaxel. All men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment. * Women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening. * Subjects must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE) Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or breastfeeding women. * Use of any other chemotherapy, radiotherapy, or experimental drug or therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment on study or those who have not recovered from adverse events ≥ grade 1 due to agents administered more than 4 weeks earlier except for stable grade 2 neuropathy. * Subjects may not receive any other concomitant investigational agents. * Known or suspected hypersensitivity to 5-azacitidine or mannitol * Known positive for HIV or infectious hepatitis, type B or C. HIV patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. * 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. * Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine.

Study Objectives The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCR in children with high-risk neuroblastoma. In the present study, a single arm trial of tandem HDCT/ASCR will be carried out. In the present study, the investigators will investigate whether tandem HDCT/ASCR might improve the survival of patients with high-risk neuroblastoma with acceptable toxicity. Conditions: Neuroblastoma Intervention / Treatment: DRUG: Cyclophosphamide, DRUG: Etoposide, DRUG: Carboplatin, DRUG: Thiotepa, DRUG: Melphalan, RADIATION: Total body irradiation 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: * Patients with high-risk neuroblastoma * Patients with intermediate-risk neuroblastoma if gross tumor remained after surgery Exclusion Criteria: * Patients with progressive disease before high-dose chemotherapy * Patients whose parents want to stop or change the planned treatment * Patients with organ toxicities of NCI grade >2 before high-dose chemotherapy

Study Objectives A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole. Conditions: Hydatidiform Mole Intervention / Treatment: DRUG: Methotrexate, DRUG: Vitamin B Complex Location: Philippines Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * diagnosis and molar evacuation done at the Department of Obstetrics and Gynecology of the Philippine General Hospital; * patients who will undergo suction curettage for evacuation of molar pregnancy; * histopathologically confirmed complete hydatidiform mole; * must have at least one of the following risk factors for the development of postmolar gestational trophoblastic disease: * uterine size larger than age of gestation of more than 6 weeks * serum B-hCG titer more than or equal to 100,000 mlU/ml * theca lutein cysts more than or equal to 6 cms in size * gravidity of 4 or more * recurrent molar pregnancy * medical complications arising from trophoblastic proliferation such as DIC, pre-eclampsia, thyrotoxicosis, pulmonary insufficiency * complete data; * patient must have at least one year of regular follow-up and hCG monitoring following onset of remission; * should have signed the consent form. Exclusion Criteria: * patients who are lost to follow-up or with incomplete data * patients who underwent total hysterectomy for evacuation of molar pregnancy * patients who are unable to complete the methotrexate treatment * patients who get pregnant within a year following remission * patients with a previous history of gestational trophoblastic neoplasia * patients with medical problems/complications that inhibit administration of methotrexate

Study Objectives Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: CS-1008 (humanized anti-DR5 antibody), DRUG: gemcitabine 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: * Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older Exclusion Criteria: * Anticipation of need for major surgery or radiation therapy during the study * Heart Disease exclusions: myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc. * Clinically significant active infection or history of HIV * Partial or complete bowel obstruction * Poorly controlled psychiatric illness

Study Objectives This study is for patients with cancer of the prostate gland that has metastasized or spread outside the prostate to other parts of the body. Patients have already been treated with a drug called docetaxel or Taxotere® (with or without the addition of a steroid called prednisone) some time in the recent past. They either did not respond to this therapy or responded to this therapy, but now the cancer is progressing (growing larger or has spread to other areas of the body). Custirsen (OGX-011) is an experimental drug that has been shown to increase the effectiveness of chemotherapy in several kinds of tumors, including prostate cancer. Both docetaxel and mitoxantrone have anticancer activity in prostate and are approved by Health Canada and the Food and Drug Administration for the treatment of patients with prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: custirsen (OGX-011)/mitoxantrone, DRUG: custirsen (OGX-011)/docetaxel Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age ≥ 18 years * Histologic diagnosis of adenocarcinoma of the prostate. * Metastatic disease on chest X-ray, bone scan, or computed tomography (CT) scan. * Failed after receiving a minimum of two cycles of a docetaxel based first line therapy regimen. Failure is defined as disease progression within 6 months of discontinuing first line docetaxel therapy. Disease progression is defined as one or more of the following: * Progressive measurable (target) disease (by Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria): at least a 20% increase in the sum of the longest diameters of measurable lesions (organ masses or lymph nodes) over the smallest sum observed (baseline or nadir) or the appearance of one or more new lesions as assessed by CT scan or chest X-ray. * Bone scan progression: one or more new lesions on bone scan while on or following docetaxel treatment. * Increasing serum PSA level: rise in PSA on three consecutive measurements obtained at least one week apart. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA will be acceptable. * Baseline laboratory values as stated below: * Creatinine ≤ 1.5 x upper limit of normal (ULN) * Bilirubin ≤ 1.1 x ULN (unless elevated secondary to conditions such as Gilbert's disease) * SGOT (AST) ≤ 1.5 x ULN * Castrate serum testosterone level (< 50 ng/mL-or-< 1.7 mmol/L). * If not treated with bilateral orchiectomy, patients must be willing to continue luteinizing hormone releasing hormone analogues throughout the study. * Adequate bone marrow function defined as absolute neutrophil count (ANC) ≥ 1.5 x 10\^9 cells/L and platelet count ≥ 100 x 10\^9/L. * Karnofsky score ≥ 60 * Received no other chemotherapy, radioisotope therapy, strontium 89, or samarium 153. (Prior radiotherapy and steroids following first line docetaxel therapy are allowed.) * Received no more than one prior biological response modifier therapy following first line docetaxel therapy. * At least 21 days since completing the last dose of docetaxel, biological response modifier, and/or radiotherapy. (Exception for radiotherapy: at least 7 days since completing a single fraction of ≤ 800 cGy to a restricted field.) * Has recovered from all therapy related toxicity to ≤ grade 2, (except alopecia and anemia.) * Willing and able to give informed consent and follow protocol requirements. Exclusion Criteria: * Life expectancy less than 12 weeks. * Patient is beyond 6 months following the last dose of docetaxel. * Patient could not tolerate a dose of docetaxel of at least 45 mg/m² at the end of first line therapy due to toxicity. * History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging in asymptomatic patients is not required.) * Current symptomatic cord compression requiring surgery or radiation therapy. (Once treated, patients are eligible for the study.) * Active second malignancy (except non melanomatous skin or superficial bladder cancer). * Prior radiotherapy to > 25% of the bone marrow. * Uncontrolled medical conditions such as a major active infection, myocardial infarction or stroke within 3 months, uncontrolled hypertension, and/or significant concurrent medical illness, that, in the opinion of the Investigator, would preclude protocol therapy. * History of or active congestive heart failure. * Known allergy or hypersensitivity to docetaxel or polysorbate 80 (diluent).

Study Objectives CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide plus low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who participated in Study CC-5013-MM-021. For subjects who remained progression free under Rd treatment of Study CC-5013-MM-02 1, this LAP offers the option to continue lenalidomide treatment for subjects who have shown therapeutic benefit. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Lenalidomide, DRUG: Dexamethasone Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Subjects who discontinued treatment but remained for long-term follow-up in the CC-5013-MM-021 study are required to sign an informed consent document (ICD) to roll over to the Safety Follow-up Phase of the Extended Access Program (EAP). These subjects do not require screening for eligibility but must agree to be followed for survival and Second Primary Malignancy (SPM) at a minimum of every 4 months (± 7 days) intervals for at least 5 years from the time the last on-study subject enrolled in Study CC-5013-MM-021. Subjects who are consented for the Treatment Phase of the EAP must meet the following criteria to continue the same therapy as they received in the Study CC-5013-MM-021: * Completed at least 1year of lenalidomide plus low-dose dexamethasone (Rd) treatment and remained progression free under Rd treatment in Study CC-5013-MM-021 at the time of screening visit of this EAP. * Able to adhere study visit schedule, compliance with study drug and other protocol requirements in Study CC-5013-MM-024. * Consented to the EAP protocol. * Must agree to comply with all Pregnancy Prevention requirements. * Females of childbearing potential (FCBP)1: * Must agree to use, and be able to comply with, at least 2 forms of reliable contraception simultaneously or to practice complete abstinence from heterosexual intercourse without interruption, from transferring/rolling over from the CC-5013-MM-021 study, at the screening visit for eligibility, throughout study drug therapy (including dose interruptions) and for 28 days after the end of study drug therapy, even if she has amenorrhea. This applies even if the subject practices complete and continued abstinence confirmed on a monthly basis. * Must agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 IU/mL (i.e., negative pregnancy test) at screening for eligibility and then every 28 days while on study. For any FCBP, pregnancy testing must continue at the same frequency as during the MM-021 study. If regular or no menstrual cycles, she must agree to ongoing pregnancy testing during the course of the study (every 28 days), during dose interruptions, at study discontinuation and 28 days following study drug discontinuation. If menstrual cycles are irregular, pregnancy testing must occur every 14 days while on study, at study discontinuation and at 14 and 28 days following study drug discontinuation. This requirement also applies to females of childbearing potential who practice complete and continued sexual abstinence. * Must agree not to breastfeed during study drug therapy and for at least 28 days following study drug discontinuation. * Male subjects: * Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and at least 28 days following study drug discontinuation. * Must agree to not donate semen or sperm during study drug therapy and for at least 28 days following study drug discontinuation. Subjects who have a positive finding of pregnancy testing at screening will not be eligible for the Treatment Phase of the EAP but will be consented for the Safety Follow-up Phase in the EAP. Exclusion Criteria: * Subjects will not continue treatment at the discretion of the physician if any of the following criteria occurred during treatment in the CC-5013-MM-021 study or during the Screening Phase. All subjects that are not eligible to continue treatment will enter the Safety Follow-up Phase: * Serious hypersensitivity or anaphylaxis to lenalidomide or dexamethasone. * Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document. * Any other condition, including the presence of serious laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Previously discontinued lenalidomide treatment due to toxicity. * Newly diagnosed malignancy other than Multiple Myeloma (MM), except the following: * Basal cell carcinoma of the skin * Squamous cell carcinoma of the skin * Carcinoma in situ of the cervix * Carcinoma in situ of the breast * Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \[TNM\] clinical staging system) or prostate cancer that is curative

Study Objectives This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells. Conditions: Anaplastic Astrocytoma, Central Nervous System Neoplasm, Glioblastoma, Gliosarcoma, Spinal Cord Neoplasm Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: Lomustine, RADIATION: Radiation Therapy, DRUG: Temozolomide 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: * Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following histologies: * Anaplastic astrocytoma * Glioblastoma multiforme * Gliosarcoma * Primary spinal cord malignant gliomas allowed * No primary brainstem tumors * Has undergone surgical resection or biopsy of the tumor within the past 31 days * Pre-operative and post-operative brain MRI with and without gadolinium-contrast OR pre-operative and post-operative spine MRI for spinal cord primaries * Post-operative MRI not required for patients who undergo biopsy only * No evidence of neuraxis dissemination * Spine MRI and cerebrospinal fluid cytology required only if clinically indicated * Performance status - Karnofsky 50-100% (for patients > 16 years of age) * Performance status - Lansky 50-100% (for patients ≤ 16 years of age) * At least 8 weeks * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) * Hemoglobin ≥ 8 g/dL (transfusions allowed) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT ≤ 2.5 times ULN * Albumin ≥ 2 g/dL * Creatinine ≤ 1.5 times ULN * Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal * No evidence of dyspnea at rest * No exercise intolerance * Pulse oximetry ≥ 94% (if determination is clinically indicated) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation * Able to swallow oral medication * Seizures allowed provided they are well controlled with anticonvulsants * No hypersensitivity to temozolomide * No prior biologic agents * No prior chemotherapy * Prior corticosteroids allowed * No concurrent corticosteroids as an antiemetic * Concurrent corticosteroids allowed only for treatment of increased intracranial pressure * No concurrent radiotherapy using cobalt-60 * See Disease Characteristics * No other prior treatment * No concurrent phenobarbital or cimetidine * No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during study chemoradiotherapy

Study Objectives This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone. Conditions: Myelodysplastic Syndromes Intervention / Treatment: DRUG: Calcitriol, DRUG: Dexamethasone Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Masking: NONE

Inclusion criteria: * Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS) * Evidence of cytopenia affecting at least 1 hematological cell lineage * Adequate liver and renal function * ECOG 0-2 * Expected survival of at least 12 weeks Exclusion criteria: * Symptomatic coronary artery disease * Uncontrolled diabetes mellitus * Uncontrolled and symptomatic glaucoma * History of dangerous reactions to steroid therapy * Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks * History of nephrolithiasis * Children * Chronic myelomonocytic leukemia (CMML)

Study Objectives The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it is given with standard chemotherapy. Conditions: Adenocarcinoma Intervention / Treatment: DRUG: Trastuzumab, DRUG: ABT-806, DRUG: Bemarituzumab, DRUG: Ramucirumab, DRUG: Nivolumab, DRUG: Standard cytotherapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed metastatic gastric or esophagogastric junction (type I,II,III Siewert) adenocarcinoma * Newly-diagnosed chemo-naïve or recurrent after curative-intent surgery * >6 months after completion of adjuvant therapy (including chemotherapy and/or radiotherapy) * No prior treatment with any targeted agent * Patients who have started first line mFOLFOX6 therapy (+/-trastuzumab for HER2 amplified tumors) may be considered for trial participation if they have received no more than 4 doses of therapy at the time of consent and screening. * Measurable metastatic disease by RECIST criteria, * Must be amenable to ultrasound or CT-guided biopsy of one metastatic lesion * Peritoneal disease as the sole site of occult metastasis or presenting as malignant ascites is acceptable if a cell block of tumor cells can be obtained showing >20% viable tumor cells. * ECOG PS 0,1 * Age > 18 years * Patients must have normal organ and marrow function as defined below: * granulocytes >1,2500/mcL * platelets >100,000/mcL * total bilirubin < 1.5 x ULN, <1.8 x ULN with liver metastases * AST(SGOT)/ALT(SGPT) <2.5 X ULN without liver metastases; <5 X ULN with liver metastases * creatinine within normal institutional limits (<1.5) OR * creatinine clearance >50 mL/min/1.73m2, (for creatinine level above normal) * INR: < 1.5 (patients on warfarin need to be converted to LMWH during study participation to be eligible) * Consent to baseline metastatic and progressive disease biopsy (of metastatic/progressing lesion) for enabling biomarker assessment and treatment assignment (at each time point - baseline, PD1, PD2, PD3) as well as for correlative studies. * Consent to baseline and serial blood draws for plasma/serum/whole blood banking for correlative studies * Ability to understand and the willingness to sign a written informed consent document and consent to the serial nature of the proposed PANGEA treatment with first, second and third line therapy as tolerated. * Ability to comply with requirements of the protocol, as assessed by the investigator by the patient signing the consent form. * If history of exposure to anthracyclines during perioperative treatment, the following cumulative doses of anthracyclines must be less than: Epirubicin < 720 mg/m2 Doxorubicin or liposomal doxorubicin < 360 mg/m2 Mitoxantrone > 120 mg/m2 and idarubicin > 90 mg/m2 If more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin. * Cardiac Ejection Fraction >50% (for HER2+ patients) as assessed by echocardiogram, MUGA scan, or cardiac MRI * Willingness to use effective and reliable methods of contraception (For appropriate methods of contraception considered acceptable see Appendix B). Both men and women and members of all races and ethnic groups are eligible for this trial. Exclusion Criteria: * No CVA within 6 months, no recent MI within 6 months * No currently active second malignancy * No uncontrolled intercurrent illness or infection * No peripheral edema > grade 2 at baseline. * No peripheral neuropathy > grade 2 at baseline. * No diarrhea > grade 2 at baseline.

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 to 80 years 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).

Study Objectives CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER Conditions: Pancreatic Cancer, Advanced or Metastatic Intervention / Treatment: DRUG: Nimotuzumab Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3

Inclusion Criteria: A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study: * written informed consent. * histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery. * measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, target lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography \[CT\] scan). * able to take medications orally. * at least18 years of age or older. * Karnofsky Performance Status (KPS) ≥ 70% (see Appendix A). * life expectancy of > 12 weeks. * adequate organ function as defined by the following criteria: * Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN). * If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN. * Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be ≤ 5 times ULN). * Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units (IU\]). * Platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L). * Hemoglobin value ≥ 9.0 g/dL. * Calculated creatinine clearance ≥ 60 mL/min (based on serum creatinine) (Cockcroft Gault formula). * willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * both female and male patients must use adequate methods of contraception. Exclusion Criteria: * had treatment with any of the following within the specified time frame prior to study drug administration: 1. Any prior anticancer chemotherapy. 2. Radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease). 3. Any radiotherapy within the previous 3 weeks. 4. Any investigational agent received either concurrently or within the last 30 days. 5. Current enrollment in another clinical trial. * Major surgery within the previous 3 weeks. * Symptomatic brain metastasis not controlled by corticosteroids. * Leptomeningeal metastasis. * Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer. * Uncontrolled ascites requiring drainage at least twice a week. * Other serious illness or medical condition(s) including, but not limited to, the following: * Uncontrolled congestive heart failure (New York Heart Association \[NYHA\] * Class III or IV, see Appendix F), angina pectoris, arrhythmias, or hypertension. * active infection. * known (at time of entry) gastrointestinal disorder, including malabsorption, * chronic nausea, vomiting, or diarrhea, present to the extent that it might interfere with oral intake and absorption of study medication. * Poorly controlled diabetes mellitus. * Psychiatric disorder that may interfere with consent and/or protocol compliance. * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study. * pregnant or lactating female. * known hypersensitivity to Anti-EGFR antibodies. * with reproductive potential who refuses to use an adequate means of contraception (including male patients).

Study Objectives This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed by a safety dose expansion part: Dose escalation part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab): Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose expected to produce during the first course of treatment dose-limiting toxicity in 33% of patients. Once the MTD has been defined, the safety expansion parts of the trial will be opened for enrollment. Safety dose expansion part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab): Patients will be treated with BEZ235, as single agent or in combination with trastuzumab, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects. Conditions: Breast Cancer, Advanced Solid Tumors, Cowden Syndrome Intervention / Treatment: DRUG: BEZ235 Location: Germany, Netherlands, Spain, United Kingdom, 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: \[Single agent dose escalation arm\]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists. \[Combination part\]: Patients with metastatic HER2+ Breast Cancer, after failure of trastuzumab treatment. Eligible patients will have to have tumors carrying molecular alterations of PIK3CA and/or PTEN. \[Single agent safety expansion arm\]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists. Patients will be prescreened for molecular alterations affecting PIK3CA and/or PTEN. Patients with NSCLC will also be pre-screened for EGFR mutation. Exclusion Criteria: * Patients who have brain metastases, which are progressive and/or requiring medical intervention for symptom control * Prior treatment with a PI3K inhibitor * Acute or chronic liver disease or renal disease * Acute or chronic pancreatitis * Patients with unresolved diarrhea ≥ CTCAE grade 2 * Impaired cardiac function or clinically significant cardiac diseases * Patients with diabetes mellitus requiring insulin treatment * Patients with known coagulopathies * Patients with a history of photosensitivity reactions to other drugs * Any of the following ophthalmological findings: * Progressive eye disease that could lead to severe loss of visual acuity or visual field * loss during the study period * Inability to perform the ophthalmic procedures required in this protocol * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol. Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives This study will assess the safety and efficacy of GPX-150 administered intravenously every 3 weeks in the treatment of patients with soft tissue sarcoma. Conditions: Soft Tissue Sarcoma Intervention / Treatment: DRUG: GPX-150 for Injection 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: * Age ≥18 years. * Histological documentation of soft tissue sarcoma (biopsy may be historical and may have been obtained from primary tumor or a metastatic site). * Advanced and/or metastatic malignant soft tissue sarcoma of intermediate or high histologic grade. Excluded are the following sarcoma subtypes: * Well-differentiated liposarcoma or atypical lipomatous tumor * Embryonal or alveolar rhabdomyosarcoma * Ewing sarcoma of soft tissue or bone * Gastrointestinal stromal tumor (GIST) * Dermatofibrosarcoma protuberans * Alveolar soft part sarcoma * Solitary fibrous tumor * Clear cell sarcoma * Kaposi sarcoma * Extraskeletal myxoid chondrosarcoma * PEComa (perivascular epithelial cell tumor) * Myoepithelioma / mixed tumor * Measurable disease as per RECIST 1.1. * Subject has received either: * No prior chemotherapy for current sarcoma, or * A single course of gemcitabine and/or docetaxel as adjuvant therapy that was completed at least 6 months prior to planned first dose * ECOG Performance Status of 0 - 2. * Adequate cardiac function: * LVEF above the institution's lower limit of normal * QTcF ≤ 450 msec for males or 470 msec for females. * Willing and able to provide written informed consent. * Male and female subjects must agree to use a highly reliable method of birth control for the duration of the study. * Women of childbearing potential must have a serum pregnancy test performed within 28 days prior to the first day of study drug dosing. Exclusion Criteria: * Sarcomas arising from bone or cartilage, e.g. chondrosarcoma, osteosarcoma, chordoma. * Subject is eligible for a potentially curative therapy. * Prior primary chemotherapy. * Prior radiotherapy to > 25% of bone marrow volume. * Treatment within 28 days prior to Dose 1 with: * Palliative surgery or radiotherapy. * Approved anticancer therapy including chemotherapy or immunotherapy. * Contraindicated treatments noted in the product labelling for doxorubicin, including trastuzumab and inhibitors and inducers of CYP3A4, CYP2D6, or P-gp. * An investigational therapy. * Any major surgery (e.g. requiring general anesthesia). * Inadequate bone marrow, liver, and renal function, as assessed by the following laboratory parameters: 1. Absolute neutrophil count (ANC) < 1,500/mm3. 2. Platelet count < 100,000/mm3. 3. Total bilirubin > 1.5×ULN (upper limit of normal). 4. ALT and AST > 2.5×ULN. For patients with documented liver metastases, ALT and AST > 5×ULN. 5. Serum creatinine > 1.5 x ULN. 6. International Normalized Ratio (INR) and activated partial thromboplastin time \[PTT\] ≥ 1.5×ULN, if not therapeutically anticoagulated. 7. Serum albumin < 3.0 gm/dL. * Congestive heart failure > Class II New York Heart Association Functional Classification, current pericarditis, myocardial infarction within 6 months, or symptomatic coronary artery disease. * Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol. * Active infection requiring systemic antibacterial/antibiotic, antifungal, or antiviral therapy. * Documented metastases to brain or meninges. * Any malignancy other than soft tissue sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors that have been successfully and curatively treated with no evidence of recurrent or residual disease. * Body surface area (BSA) ≥ 2.4 m2. * Currently pregnant or nursing. * Known allergy to any of the study drugs or their excipients.

Study Objectives This study is a Phase 1 dose-escalation open-label study to determine the recommended Phase II dose (RP2D) and regimen for the combination of the orally administered MEK inhibitor GSK1120212 and the orally administered AKT kinase inhibitor GSK2141795. The study consists of two parts. Part 1A will identify the maximum tolerated dose (MTD) using a Zone-Based, modified 3 plus 3 dose escalation procedure. The starting dose (Zone 1, Cohort 1) will be 0.5mg GSK1120212 combined with 25mg GSK2141795. Dose escalation will continue based on predefined parameters until a MTD is established. The initial regimen for dose escalation in Part 1A will be continuous oral daily dosing. Once the continuous daily dosing MTD or RP2D has been established in Part 1A, Part 1B will explore alternate dosing schedule(s) in which the dosing schedule may be adjusted for either GSK1120212 or GSK2141795. Dose escalation will proceed using a 3 plus 3 dose escalation procedure until an MTD or RP2D of that alternate schedule is defined. Part 2 will explore further in specific tumor types the safety, tolerability, clinical activity, pharmacokinetic (PK) and pharmacodynamic (PD) properties of the combination of GSK1120212 and GSK2141795 at the recommended dose(s) and regimen(s) identified in Part 1. Conditions: Cancer Intervention / Treatment: DRUG: GSK1120212, DRUG: GSK2141795 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: Part 1 - Dose Escalation Subjects eligible for enrollment in the study must meet all of the following criteria: Male or female 18 years or older, at the time of signing the informed consent. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Histologically or cytologically-confirmed diagnosis of solid tumor malignancy that is not responsive to standard therapies or for which there is no approved or curative therapy or for subjects who refuse standard therapy (Part 1A). Part 1B subjects must have a confirmed diagnosis of one of the following (documented lab results confirming mutational status must be available at Screening): colorectal cancer (CRC): KRAS mutation non-small cell lung (NSCLC): KRAS mutation Pancreatic: no mutational status specified Endometrial: no mutational status specified Ovarian: no mutational status specified Squamous cell carcinoma of the head and neck: no mutational status specified BRAF wild type melanoma (preferentially enrolled to Part 2) BRAF inhibitor failure melanoma. This includes BRAF-mutant melanoma that is either initially refractory to BRAF-inhibitor therapy OR that Initially responds to BRAF-inhibitor therapy but eventually develops documented radiographic progression to a BRAF inhibitor while on therapy Triple negative breast cancer (TNBC) (preferentially enrolled to Part 2) NOTE: Subjects who do not meet one of the categories described above but who have molecular evidence suggesting benefit from the study drugs may be considered for enrollment after discussion with the GlaxoSmithKline (GSK) Medical Monitor. Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. Able to swallow and retain oral medication. Must agree to collection of blood samples for the evaluation of circulating free DNA (cfDNA) (Part 1B or Part 2). A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] greater than 40 MlU/ml and estradiol less than 40 pg/ml \[less than 140 pmol/L\] is confirmatory). Females on hormone replacement therapy \[HRT\] and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Child-bearing potential and agrees to use one of the contraception methods listed in Section 7.3.2 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Additionally, women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to the first dose of study medication. Female subjects must agree to use contraception until four weeks after the last dose of study medication. Note: Oral contraceptives are not reliable due to potential drug-drug interaction and should only be used in combination with the alternative methods outlined in Section 8.1.1. Male subjects must agree to use one of the contraception methods listed in Section 8.1.2. This criterion must be followed from the time of the first dose of study medication until four months after the last dose of study medication. Adequate organ system function as defined in protocol. Absolute neutrophil count (ANC) greater than or equal to 1.5 X 10 to the ninth/L Hemoglobin greater than or equal to 9.5 g/dL Platelets greater than or equal to 75 X 10 to the ninth/L Prothrombin time (PT) / International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) less than or equal to 1.1 X ULN Total bilirubin less than or equal to 1.5 x ULN (isolated bilirubin greater than 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35 percent) AST and ALT less than or equal to 1.5 X ULN Albumin greater than 2.5 g/dL Creatinine less than or equal to ULN OR Calculated creatinine clearance greater than or equal to 30 mL/min OR 24-hour urine creatinine clearance greater than or equal to 30 mL/min Fasting Serum Glucose les than 126mg/dL Cardiac Ejection fraction greater than or equal to lower limit of normal (LLN) by ECHO Inclusion Criteria for Part 2 - Expansion Cohort: Histologically- or cytologically-confirmed diagnosis of one of the following: Triple negative (estrogen receptor(ER)-/ progesterone receptor(PR)-/ human epidermal growth factor receptor 2 (HER2)) breast cancer in the locally advanced or metastatic setting BRAF-wild type melanoma. Based on emerging data, subjects with these tumor histologies may be required to meet specific genetic selection criteria if those criteria are felt to improve the likelihood that a given subject will respond to study drug(s). If this is to occur, the site and the Investigational Review Board (IRB) will be notified but this change will not constitute a protocol amendment. Known Phosphatase and tensin homolog (PTEN) status of tumor. At least 6 of the subjects enrolled in Stage 1 with each tumor type will have PTEN deficiency while at least 6 others will be PTEN wild type. If the subject's tumor PTEN status was previously determined by an acceptable, analytically validated assay (i.e., Immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), sequencing, copy number analysis) then PTEN by IHC at Screening will not need to be repeated for the purpose of enrollment in this study. However, archival tumor tissue or tissue from a fresh biopsy specimen should be submitted for confirmation of PTEN status by a central laboratory using IHC. If PTEN status was not previously determined, archival tissue from a previous tumor biopsy specimen must be available for PTEN IHC analysis; if archival tissue is not available or found to not contain tumor tissue, a fresh biopsy is required to obtain tumor tissue for testing. Subjects in Part 2 that have been previously diagnosed with Type 2 diabetes must also meet the additional following criteria: Diagnosis of diabetes greater than or equal to 6 months prior to enrolment HbA1C less than or equal to 8 percent at Screening visit Exclusion Criteria Subjects meeting any of the following criteria must not be enrolled in the study: Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including investigational drugs within 28 days or 5 half lives, whichever is shorter prior to the first dose of any one of the investigational drugs described in this study. Prior exposure to either a MEK inhibitor or an AKT inhibitor is not permitted. Current use of a prohibited medication or requires any of these medications during treatment with the study treatments. Unresolved toxicity greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (NCI-CTCAE v4) Grade 1 from previous anti-cancer therapy unless agreed to by a GSK Medical Monitor and the Investigator, and where a GSK Medical Monitor and the investigator consider that the ongoing toxicity will not introduce additional risk factors and will not interfere with the study procedures. Presence of active gastrointestinal (GI) disease or other condition that could affect gastrointestinal absorption (e.g. malabsorption syndrome) or predispose a subject to GI ulceration. Subjects with prior Whipple procedure are eligible. Evidence of mucosal or internal bleeding. Any major surgery within the last four weeks. Previously diagnosed with Type 1 diabetes mellitus. Previously diagnosed with Type 2 diabetes (Part 1A or Part 1B ONLY). Subjects with a history of steroid-induced hyperglycemia may be enrolled. Any malignancy related to human immunodeficiency virus (HIV), history of HIV, history of known hepatitis B virus (HBV) surface antigen positivity (subjects with documented laboratory evidence of HBV clearance may be enrolled) or positive hepatitis C virus (HCV) antibody. Known active infection requiring parenteral or oral anti-infective treatment. Subjects with leptomeningeal disease. Subjects with brain metastases are excluded if their brain metastases are: Symptomatic Treated (e.g., surgery, radiation therapy) but not clinically and radiographically stable one month after therapy (as assessed by at least two distinct contrast enhanced magnetic resonance imaging (MRI) or computerized axial tomography (CT) scans over at least a one month period), OR Asymptomatic and untreated but greater than 1 cm in the longest dimension Subjects with small (less than or equal to 1 cm in the longest dimension), asymptomatic brain metastases that do not need immediate therapy can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for more than 4 weeks. Part 1B: Subjects with brain metastases who have been off corticosteroids for at least 2 months can be enrolled. Part 2 (A or B): Subjects with brain metastases on a stable (i.e., unchanged) dose of corticosteroids for more than one month, or those who have been off corticosteroids for at least 2 weeks can be enrolled. QTcF interval greater than or equal to 480 milliseconds (msecs) (greater than or equal to 500 msec for subject with bundle branch block). History or evidence of current clinically significant uncontrolled arrhythmias. Subjects with controlled atrial fibrillation for greater than 1 month prior to study Day 1 are eligible. History of acute coronary syndromes (including unstable angina), myocardial infarction, coronary angioplasty, or stenting or bypass grafting within six months of Screening. Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. Other clinically significant electrocardiography (ECG) abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. Subject with intra-cardiac defibrillators or pacemaker. Presence of cardiac metastases. Any serious or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject's safety or providing informed consent. Known immediate or delayed hypersensitivity to any of the components of the study treatment(s). Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease, including unstable hypertension). Pregnant or lactating females. History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): History of RVO or CSR, or the presence of predisposing factors to RVO or CSR at the time of screening (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes). Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as: Evidence of new optic disc cupping Evidence of new visual field defects Intraocular pressure greater than 21 mm Hg as measured by tonography

Study Objectives The objective of this study is to evaluate the safety, tolerability, and antitumor activity of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in participants with metastatic pancreatic cancer. Conditions: Carcinoma, Metastatic Pancreatic Adenocarcinoma Intervention / Treatment: DRUG: Oleclumab, DRUG: Durvalumab, DRUG: Gemcitabine, DRUG: Nab-paclitaxel, DRUG: Oxaliplatin, DRUG: Folinic acid, DRUG: 5-FU Location: United States, Spain, Australia, Norway Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >= 18 * Written and signed informed consent must be obtained * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Weight >= 35 kg * Participants must have histologically or cytologically, confirmed pancreatic adenocarcinoma: Cohort A: Participants with previously untreated metastatic pancreatic adenocarcinoma (1L metastatic disease) not previously treated with systemic therapies Cohort B: Participants with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2L metastatic disease * Participants must have at least 1 measurable lesion according to RECIST v1.1 * All Participants must consent to providing archival tumor specimens. Exclusion Criteria: * Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment. * Prior receipt of any immune-related therapy * Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed. * Participants with a history of venous thrombosis within the past 3 months * Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment * Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment * Other invasive malignancy within 2 years * Any history of leptomeningeal disease or cord compression * Current or prior use of immunosuppressive medication within 14 days prior to the first dose.

Study Objectives The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy Conditions: Prostate Cancer Intervention / Treatment: DRUG: BN83495 (Cohort 1), DRUG: BN83495 (Cohort 2), DRUG: BN83495 (Cohort 3) 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: * Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy. * Over age 18. * Demonstrated PSA "biochemical failure". * Adequate bone marrow and hepatic function Exclusion Criteria: * Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy * Prior treatment with ketoconazole * Prior chemotherapy for hormone refractory prostate cancer * Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo

Study Objectives The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for up to twelve weeks. A second purpose is to evaluate the safety of the drug. Conditions: Warts Intervention / Treatment: DRUG: Resiquimod Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * Diagnosis of common wart(s) * Ages between 3 to 11 Exclusion Criteria: * Other types of wart(s), ie. plantar * Currently participating in another clinical study * Chronic viral hepatitis B or C

Study Objectives The purpose of this study is to test the safety of an investigational drug called LB-100 for Injection for treatment of solid tumors, when given with or without docetaxel. LB-100 is a small molecule that in laboratory and animal studies has shown activity when used by itself or together with drugs approved to treat some types of cancer (chemotherapeutic agents). Docetaxel is a drug that has been approved for the treatment of some types of cancer; one of the trade names for docetaxel is Taxotere®. The study is in 2 parts. Part 1: Patients will receive injections of LB-100. Part 2: Patients will receive injections of LB-100 and docetaxel. This is the first study where LB-100 for Injection will be used in humans. Conditions: Tumors, Neoplasms, Cancer Intervention / Treatment: DRUG: LB-100 for Injection, DRUG: Docetaxel 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: * Part 1 only: Patients with histologically or cytologically proven progressive or metastatic solid tumors who have failed standard treatment and have no other effective treatment available. Part 2 only: Patients with histologically or cytologically proven progressive or metastatic solid tumors who have failed standard treatment and have no other effective treatment available, or docetaxel-naive patients who have failed standard treatment and have tumors for which a docetaxel-based regimen would be appropriate. * Part 2 only: Patients must be docetaxel-naive. * Patients must have a life expectancy of at least 12 weeks. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Patients must be men and women >= 18 years of age. * Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or <= grade 1 prior to study entry. * Patients must have adequate bone marrow function, defined as an absolute neutrophil count >= 1.5 x 10\^9/L and a platelet count >= 100 x 10\^9/L. * Patients must have adequate renal function, defined as serum creatinine <= 1.5 x upper limit of normal (ULN) for the institution or a calculated creatinine clearance \[Cockcroft-Gault method\] must be >= 60 mL/min/1.73 m\^2). * Patients must have adequate hepatic function, defined as: * Part 1 only: plasma total bilirubin <= 1.5 mg/dL, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 X ULN. * Part 2 only: plasma total bilirubin <= ULN; ALT and/or AST <= 1.5 X ULN concomitant with alkaline phosphatase <= 2.5 X ULN. * Female patients of childbearing potential must have a negative serum or urine pregnancy test result at time of pre-treatment screening. * Patients with reproductive potential must agree to use at least one form of barrier contraception prior to study entry and for up to 30 days beyond the last administration of study drug. * Patients must be capable of providing informed consent and must be willing to provide written informed consent prior to the start of any study-specific procedures. Exclusion Criteria: * Patients may not have had prior chemotherapy, radiotherapy, hormonal therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study. * Part 2 only: Patients may not have had prior treatment with docetaxel. * Part 2 only: Patients with plasma total bilirubin > ULN; ALT and/or AST > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN. * Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following: * Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias. * Active infection. * Unstable diabetes mellitus. * Psychiatric disorder that may interfere with consent and/or protocol compliance. * Uncontrolled seizure activity. * Prior history of inflammatory bowel disease. * Prior history of pulmonary fibrosis. * Prior history of cardiomyopathy. * Patients with a history of central nervous system (CNS) malignancy. * Pregnant or breastfeeding women. * Patients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer, or carcinoma in situ (either cervix or breast) that does not require further treatment. * Patients with known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. * Part 2 only: Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 (for example, drugs formulated with polysorbate 80 include, but are not limited to: Aranesp, Eprex, Cordarone, some vaccines). * Part 2 only: Patients with >= grade 2 peripheral neuropathy. * Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.

Study Objectives To determine the maximal tolerated dose (MTD) of axitinib in combination with RT for advanced HCC. Conditions: Advanced Hepatocellular Carcinoma (HCC) Intervention / Treatment: DRUG: Axitinib, RADIATION: Radiation Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age of 20-85 years, with ECOG performance 0-2. * Advanced hepatocellular carcinoma (HCC), histologically or clinically diagnosed. (Multiple tumors, portal vein thrombosis, nodal metastasis or distant metastasis is allowed.) * Unsuitable for resection, liver transplantation, radiofrequency ablation (RFA) or transarterial chemoembolization (TACE), or recurrent / refractory after prior local-regional treatment. * ≥ One measurable tumor. * Child-Pugh score A or B. * Patients who fulfill all of the following criteria: 1. Serum total bilirubin ≤ 3 mg/dL 2. Serum alanine transaminase (ALT) ≤ 5 times ULN 3. INR ≤ 2.20 4. Platelet count ≥ 50,000 /mm3 5. WBC count ≥ 3,000 /mm3 or ANC ≥ 1,500 /mm3 6. Serum creatinine ≤ 2.0 mg/dL * Normal thyroid function confirmed. * Absence of grant for sorafenib. * Sorafenib failure or intolerability (if ever used). Exclusion Criteria: * Considered to have high risk of bleeding (e.g. active peptic ulcer, unstable esophageal/gastric varices, history of aneurysm, and requirement of anticoagulant therapy). * Pre-existing uncontrolled hypertension (systolic >140 mmHg, diastolic >90 mmHg) or proteinuria ≧500 mg/24 hours. * Prior history of coronary artery disease. * The patient is participating in other clinical trials. * Pregnant women. * Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. * Patients with non-healing wound. * Requiring the use of potent CYP3A4/5 inhibitors or inducers (see Appendix). * Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Study Objectives This phase II trial studies how well brentuximab vedotin before autologous (taken from an individual's own cells) stem cell transplant works in treating patients with Hodgkin lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Conditions: Recurrent Hodgkin Lymphoma, Refractory Hodgkin Lymphoma Intervention / Treatment: DRUG: brentuximab vedotin 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 documented or cytologically confirmed Hodgkin lymphoma with CD 30 expression * Patients must have absolute neutrophil count (ANC) >= 1000/uL; neupogen (filgrastim) can be given prior to start of SGN-35 (brentuximab vedotin) and during SGN-35 treatment to achieve target ANC >= 1000/uL * Patients must have platelets (Plts) >= 50,000/uL; platelet transfusion can be given prior to the start of SGN-35 and during SGN-35 treatment to achieve a target plt >= 50,000/uL * Patients must have measurable disease > 1.5 cm evidenced by computed tomography (CT) scan of the neck/chest/abdomen(abd)/pelvis or CT/positron emission tomography (PET) scans * Patient must be either primary refractory to one frontline induction therapy or relapsed after one frontline induction therapy; patients who do not achieve complete remission after induction therapy are also eligible * Patients cannot have had a second line salvage treatment (chemotherapy, biologic agents, investigational drugs, or radiation) or have had an autologous or allogeneic hematopoietic stem cell transplantation; patients can have had mixed frontline therapy such as 2-4 cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) followed by 2-4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) as long as the induction chemotherapy is not more than 8 cycles in total length * Radiation use as part of induction regimen or consolidation (within 90 days after completion of induction chemotherapy) is allowed * 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 (i.e., 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 of contraception for the duration of the study * Life expectancy of greater than 3 months * Karnofsky performance status of > 60% * ANC >= 1000/uL * Plts >= 50,000/uL * Total bilirubin within 1.5 x of the upper limit of normal (ULN) institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 X institutional ULN (unless demonstrated Hodgkin lymphoma involvement of the liver) * Calculated creatinine clearance >30 ml/min (unless demonstrated Hodgkin lymphoma involvement of the kidney) ELIGIBILITY FOR 2.4 MG/KG DOSING IN THE NEW COHORT: * In addition to the inclusion/exclusion criteria outlined, to be eligible for treatment with the higher 2.4 mg/kg dose of brentuximab vedotin in the new cohort of 20 additional patients, best response after 2 cycles of brentuximab vedotin administered at the 1.8 mg/kg dose, must be partial remission (PR) or stable disease (SD) as determined by radiographic imaging Exclusion Criteria: * Patient has > 1.5 x ULN total bilirubin, unless history of Gilbert's syndrome * Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant * Patient has hypersensitivity to brentuximab vedotin * Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women * Patient has received other investigational drugs within 14 days before treatment of treatment with brentuximab vedotin * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy * Patients with other active malignancies (no evidence of other cancer or life expectancy greater than 5 years) are ineligible for this study * Patients with active central nervous system (CNS) disease or history of brain metastases (mets) are excluded from study * Patients may be on steroids prior to initiation of treatment as long as by cycle 1 day 1 steroids use was tapered down less than or equal to 20 mg of prednisone.

Study Objectives The primary reason for this study is to determine whether the addition of VELCADE (bortezomib) for injection to standard melphalan/prednisone (MP) therapy improves the time to disease progression (TTP) in subjects with previously untreated multiple myeloma. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: bortezomib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: * Male or female * Not a candidate for HDT/SCT due to: age - subject is 65 years or older or in subjects less than 65 years of age - presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT/SCT. * Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage. Asymptomatic multiple myeloma-related organ or tissue damage can include presence of asymptomatic lytic bone lesion or plasmacytoma, or presence of anemia, renal function impairment, or hypercalcemia, as long as the criteria for pre-treatment clinical laboratory values indicated below are met. * Presence of measurable disease, defined as: * For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value. * For oligosecretory or nonsecretory multiple myeloma, measurable disease is defined by the presence of measurable soft tissue or organ (not bone) plasmacytomas as determined by clinical examination or applicable radiographs. * Karnofsky performance status score of equal or greater then 60%. * Willing and able to complete the PRO instruments * Agrees to use an acceptable barrier method for contraception for the duration of the study (for male subjects); If female subjects are still having menstrual periods and are not surgically sterile, they must be practicing an effective method of birth control before entry, and throughout the study, and have a negative serum B-HCG pregnancy test at screening. * Have pretreatment clinical laboratory values meeting the criteria as described in the protocol within 14 days before randomization. * Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: * Diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less. * Diagnosis of Waldenström's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions * Prior or current systemic therapy for multiple myeloma including steroids (with the exception of emergency use of a short course \[maximum of 4 days\] of steroids before randomization or of prior or current use of bisphosphonates) * Radiation therapy within 30 days before randomization * Plasmapheresis within 30 days before randomization * Major surgery within 30 days before randomization (kyphoplasty is not considered major surgery) * History of allergic reaction attributable to compounds containing boron or mannitol * Peripheral neuropathy or neuropathic pain Grade 2 or higher. * Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis * Other malignancy within the past 5 years. Exceptions if treated and not active include the following: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix * Concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes) that is likely to interfere with study procedures or results, or that, in the opinion of the investigator would constitute a hazard for participating in this study * Use of any investigational drugs within 30 days before randomization * Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator.

Study Objectives Characteristics of patients with Neuregulin-1 (NRG1) gene fusion-positive solid tumors treated with afatinib, and characteristics of those treated with another systemic therapy. Conditions: Non-squamous, Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Afatinib, DRUG: other systemic therapy Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adults, 18 years of age or older, at the time of diagnosis with any solid tumor. * Confirmed NRG1 gene fusion in any solid tumor. * Initiated afatinib or other systemic therapy (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01/01/2017 through 03/31/2020. * Followed up for ≥3 months after initiation of afatinib or other systemic therapy (unless deceased prior to 3 months of follow-up). Exclusion Criteria: * Treatment with any Tyrosine kinase inhibitor (TKI)/ErbB-directed therapy other than afatinib

Study Objectives The aim of the study is to evaluate the effect of Gelronate gel, NaHA based product (medical device for topical application) vs. Aloevera gel, in prevention or minimizing of radiation induced skin reaction in breast cancer patients Conditions: Radiation Dermatitis Intervention / Treatment: DEVICE: Gelronate, OTHER: Aloevera Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Female patients aged at least 18 years with unilateral breast following lumpectomy +/- chemotherapy * Planned to receive 42.4 Gy whole breast irradiation +/- boost to tumor bed. * ECOG performance status 0-2. * Capable of giving written informed consent. * No co-morbidities known to affect radiotherapy reactions. * No co-existing acute or chronic skin disease. * No evidence of infection or inflammation of breast to be treated. * Not receiving chemotherapy during radiotherapy course. Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study. Exclusion Criteria: * Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation. * Prior radiotherapy to the chest wall. * Collagen vascular disease. * Participation in other clinical study.

Study Objectives The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL). Conditions: B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Well-differentiated Lymphocytic Lymphoma, B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, Waldenstrom Macroglobulinemia, Burkitt Lymphoma, B-Cell Diffuse Lymphoma Intervention / Treatment: DRUG: PCI-32765 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: * Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia \[WM\], mantle cell lymphoma \[MCL\], and diffuse large B cell lymphoma \[DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug. * Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion. * Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential. * Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations). Exclusion Criteria: * A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk * Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection. * Lactating or pregnant

Study Objectives The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis (SPMS). Conditions: Autoimmune Diseases of the Nervous System, Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Disease Progression, Brain Atrophy Intervention / Treatment: BIOLOGICAL: Tcelna, BIOLOGICAL: Placebo Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Diagnosed with MS as defined by the modified McDonald criteria * SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits * EDSS score 3.0 - 6.0, inclusively * Presence of myelin reactive T-cells Exclusion Criteria: * Diagnosed with primary progressive MS * Treatment with beta-interferon, glatiramer acetate or dimethyl fumarate 30 days prior to screening * Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening * Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening * Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to baseline * Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab * Previous treatment with any other MS investigational drug 1 year prior to screening * All non-MS investigational drugs must have a minimum washout of 30 days prior to screening or 5 half-lives, whatever is the longest period of time. * HIV or hepatitis infection * History of cancer * Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair.

Study Objectives Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy. Objectives: To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for patients with B cell malignancies. Eligibility: Patients between 1 and 80 years of age, who have relapsed or refractory CD19-expressing B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments. Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria are eligible to participate. Patients must have adequate organ functions. Design: Peripheral blood from patients will be collected for isolation of peripheral blood mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral vector encoding anti-CD19 CAR containing a CD28 or 4-1BB and a CD3 zeta as costimulatory domains. Patients will receive a lymphodepleting preconditioning regimen to prepare their immune system to accept modified T cells. Patients will receive an infusion of their own modified T cells. They will remain in the hospital to be monitored for adverse events until they have recovered from the treatment. Patients will have frequent follow-up visits to monitor the persistence of modified T cells and efficacy of the treatment. Conditions: Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Lymphoma Intervention / Treatment: COMBINATION_PRODUCT: Drugs and Anti-CD19-CAR transduced T cells Location: China 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 CD19+ B cell malignancy，including relapsed or refractory B cell leukemia and B cell lymphoma； * Patients with CD19+ B cell malignancies are not able to receive standard treatments and willing to participate in the trial; * Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis； * patients are not eligible for autologous or allogeneic stem-cell transplantation (SCT) or relapsed after autologous or allogeneic stem-cell transplantation； * Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease and no longer taking immunosuppressive agents during the treatment. * Willing to sign a durable power of attorney； * Able to understand and sign the Informed Consent Document； * Performance status：ECOG 0-2； * Life expectancy：More than 3 months； * Patients of both genders must be willing to practice birth control for four months after receiving a lymphodepleting preconditioning regimen； * Female participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion, because of the potentially dangerous effects on the fetus； * There is no obvious dysfunctions in heart , liver and kidney, and the functions of vital organs are normal； * Serology： (1) Seronegative for HIV antibody； (2) Seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV). * More than three weeks must have elapsed since any prior systemic therapy at the time of randomization, and patients' toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo)； * Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram； * More than 30 days must have elapsed since Monoclonal antibody therapy administered prior to apheresis. Exclusion Criteria: * Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression； * Patients that have active hemolytic anemia； * Patients with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases, or any residual intracranial implants； * Women of child-bearing potential who are pregnant or breastfeeding； * Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system； * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)； * Concurrent opportunistic infections； * Concurrent Systemic steroid therapy； * History of severe immediate hypersensitivity reaction to any of the agents used in this study； * Patients with central nervous system (CNS) metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions)； * CNS-3 disease or traumatic spinal tap with POSITIVE Steinherz/Bleyer algorithm with cerebral spinal fluid involvement with malignancy will make any patient not eligible for this protocol； * Patients with cardiac atrial or cardiac ventricular lymphoma involvement； * Other anti-neoplastic investigational agents currently or within 30 days prior to start of the treatment； * Previous treatment with any gene therapy products.

Study Objectives To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose following laparoscopic pelvic surgery (radical prostatectomy). Conditions: Prostate Cancer, Postoperative Adhesion Intervention / Treatment: DRUG: hyaluronic acid-carboxymethylcellulose Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Men who were 50-75 years old and diagnosed with prostate cancer were eligible if they were scheduled to undergo laparoscopic pelvic surgery (radical prostatectomy). Exclusion Criteria: * any history of abdominal or pelvic surgery, hypersensitivity or an allergic reaction to the study material, pelvic lymph node dissection at the same time as prostatectomy, the presence of surgical site infection or contamination, a history of a medical disease causing bowel adhesion, or a history of severe drug allergies.

Study Objectives A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients. Conditions: Premalignant Vulvar Lesion, Benign Vulvar Lesion Intervention / Treatment: DRUG: Cefazolin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * All women, >=18 undergoing vulvar surgery * Biopsy proven benign or premalignant lesion requiring surgical management. * Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery. * Scheduled to undergo surgical management for their vulvar disease supervised by a faculty member within the Division of OBGYN at Washington University School of Medicine * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * Women who are pregnant * Women scheduled to undergo a radical vulvectomy * Women scheduled to undergo a concomitant graft, flap or plastic surgery * Women <18 years of age * History of prior vulvar radiation * Inability to sign an informed consent form prior to registration on study * Inability to understand spoken or written English * Prisoner

Study Objectives The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer. Conditions: Esophageal Cancer Intervention / Treatment: DRUG: Irinotecan, DRUG: Cisplatin, PROCEDURE: Radiation, PROCEDURE: Surgery, DRUG: sunitinib (Sutent) Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically proven squamous or adenocarcinoma or the esophagus >20 cm from the incisors, including GE junction tumors (unless of gastric origin). * Tumors must be technically resectable. * Clinical T1N1M0, T2-3 N0-1 M0 * Performance status ECOG 0-1 * Medically fit for chemotherapy, radiation and esophagectomy Exclusion Criteria: * In situ or clinical T1N0M0, and stage IV (M1a orM1b) * Cervical esophageal tumors (within 20 cm of the incisors) * Age <18 or >70 * Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy * known or suspected drug or alcohol abuse * Prior treatment for this malignancy except esophageal stenting

Study Objectives PRIMARY OBJECTIVES: Determine the safety and tolerability of nilotinib in steroid dependent / refractory cGVHD. SECONDARY OBJECTIVES: Determine the clinical efficacy of nilotinib in steroid dependent / refractory cGVHD. Conditions: Bone Marrow Transplant Failure, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Peripheral Intervention / Treatment: DRUG: Nilotinib Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria:5.1.1 Steroid dependent/refractory cGVHD defined as: * Dependent disease - Persistent cGVHD manifestations requiring a glucocorticoid dose >= prednisone 0.25 mg/kg/day (0.5 mg/kg po qod) for at least 12 weeks. * Refractory disease - Progressive cGVHD manifestations despite treatment with a glucocorticoid dose >= prednisone 0.5 mg/kg/day (1 mg/kg po qod) for at least 4 weeks. *1.2 Any previous treatments for cGVHD (except nilotinib). Participants may have received nilotinib for other reasons besides cGVHD such as leukemia or solid tumor. *1.3 Participants must be receiving baseline systemic glucocorticoid therapy for cGVHD at study entry. The dose of steroids must be stable for 14 days prior to starting nilotinib. *1.4 At the time of trial enrollment, participants may be receiving one or two other immunosuppressive therapies in addition to glucocorticoids. Immunosuppressant doses must be stable for 14 days prior to starting nilotinib. Monoclonal T or B cell antibodies must be discontinued at least 28 days before starting nilotinib. *1.5 Chronic GVHD manifestations that can be followed on physical or laboratory exam. A list of potential manifestations is presented in Appendix D. * Skin changes * Oral mucosa changes * Hepatic dysfunction *1.6 >= 18 years old *1.7 Life expectancy >= 6 months. *1.8 Karnofsky performance status >= 60 (defined as being unable to work, able to live at home, and able to care for most personal needs but requiring occasional assistance from others). *1.9 Laboratory parameters: * Creatinine < 1.5 x ULN * ANC > 1.5 x 10\^9/L * Platelets > 100 x 10\^9/L * Total bilirubin < 1.5 x ULN * AST (SGOT) and ALT (SGPT) < 2.5 x ULN * Serum amylase and lipase <= 1.5 x ULN * Alkaline phosphatase <= 2.5 x ULN * Patients must have the following laboratory values within normal limits at the local institution lab or corrected to within normal limits with supplements prior to the first dose of study medication: Potassium Magnesium Phosphorus Calcium *1.10 Oxygen saturation during exertion maintained at >= 88% on room air. *1.11 Ability to understand and willingness to sign a written informed consent form. *1.12 Females with reproductive potential must have a negative pregnancy test <= 7 days before starting nilotinib. Reproductive potential will be defined as having at least 1 menstrual period in the past 12 months. Male and female subjects with reproductive potential agree to the use of barrier contraception during their treatment and for up to 3 months after the last dose. *1.13 Careful rationalization of concomitant medications with the intent to discontinue or change to alternative medications when any concomitant medications are identified that have the potential to prolong the QTcB interval or are associated with an increased risk of torsades de pointes. (Appendix B) *1.14 . Careful rationalization of concomitant medications with the intent to discontinue or change to alternative medications if any concomitant medications are identified to be strong CYP3A4 inhibitors. (Appendix C) *1.15 Myeloablative or non-myeloablative allogeneic hematopoietic cell transplant. Exclusion Criteria:5.2.1 Currently receiving or has received within 28 days of starting study drug nilotinib or any other tyrosine kinase inhibitor. *2.2 Received any anti-T or anti-B cell monoclonal antibody <= 28 days prior to the anticipated start of study drug. *2.3 Currently receiving > two immunosuppressants other than glucocorticoids. *2.4 Currently receiving a calcineurin inhibitor and sirolimus *2.5 Received any investigational agents <= 28 days before starting nilotinib. *2.6 Impaired cardiac function including any one of the following: * Clinically significant resting brachycardia (<50 beats per minute). * QTc > 450 msec on baseline ECG. If QTc >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. * Myocardial infarction within 12 months prior to starting study. * Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension). * History of or presence of clinically significant ventricular or atrial tachyarrhythmias. (including congenital long QT syndrome or a known family history of congenital long QT syndrome) *2.7 Allogeneic cell infusion within 100 days *2.8 Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines. *2.9 Progressive malignant disease including post transplant lymphoproliferative disease. *2.10 Any secondary malignancy except basal and squamous cell carcinoma of the skin within the past five years. *2.11 Nilotinib intolerance or hypersensitivity. 5.2.12 Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection or gastric bypass surgery). *2.13 Acute or chronic pancreatic disease 5.2.14 Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery. *2.15 Subject is pregnant, breast-feeding, or of childbearing potential without a negative serum or urine pregnancy test within 7 days of enrollment. Male or female patients of childbearing potential unwilling to use effective contraceptive precautions throughout the trial. *2.16 Subject not willing to comply with treatment or response evaluation (including associated procedures such as skin biopsy). *2.17 Subject has a concurrent illness which in the opinion of the investigator may interfere with the treatment and evaluation of the patient.

Study Objectives This phase II study is designed to determine the clinical efficacy of PD-1 blockade, using the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475), administered as consolidation therapy after autologous stem cell transplant (ASCT), in patients with relapsed or refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL), classical Hodgkin Lymphoma (cHL) or peripheral T-cell lymphoma (PTCL) in 1st remission. Conditions: Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Peripheral T-Cell Lymphoma Intervention / Treatment: DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria * Histologically confirmed diagnosis with review of the diagnostic pathology specimen at one of the participating institutions. Eligible histologies are: Arm A: Diffuse large B cell lymphoma; patients with a prior history of indolent B-cell NHL are eligible, as long as they have histologically confirmed DLBCL prior to their pre-transplant salvage treatment. Patients with mediastinal large B cell lymphoma are also eligible. Arm B: Classical Hodgkin lymphoma (patients with nodular lymphocyte predominant Hodgkin lymphoma \[NLPHL\] are NOT eligible) Arm C: Peripheral T cell lymphoma - eligible subtypes will include PTCL, NOS; AITL; and ALK-negative ALCL. Patients with other PTCL histologies, including ALK-positive PTCL, and cutaneous T-cell lymphoma will not be eligible.. * Age ≥ 18 at the time of enrollment. * For arms A and B, participants must have relapsed after or been refractory to first-line chemotherapy, i.e., they must have failed to achieve CR after first-line therapy or must have relapsed subsequently if they achieved CR. For arm C, participants will be eligible if transplant is performed as consolidation of first remission (partial or complete). * Participants must be planning to receive or have received autologous stem cell transplantation. Participants must have chemosensitive disease prior to ASCT, defined as achieving at least a partial remission (as determined with PET imaging) to salvage treatment. Participants with cHL or DLBCL (arms A and B) transplanted in 1st remission after only one line of treatment are not eligible. Participants with PTCL (arm C) transplanted beyond 1st remission are also not eligible. * No more than 1 line of anthracycline-containing chemotherapy prior to ASCT, and no more than 3 lines of therapy total prior to ASCT for arms A and B; no more than 1 line of therapy prior to ASCT for arm C. * Participants cannot have received any anti-neoplastic therapy (including radiotherapy, chemotherapy or immunotherapy) after ASCT * Participants must have had PET-CT for restaging after salvage therapy and before ASCT. * Participants must begin study treatment no later than 21 days from the post-ASCT discharge. Additionally, they must have recovered from ASCT toxicities at the time of first study treatment. * ECOG performance status ≤2 * Participants must have normal organ and marrow function as defined below: * absolute neutrophil count ≥ 1,000/mcL * platelets ≥ 50,000/mcL * Hemoglobin ≥ 8 g/dl * total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), or direct bilirubin ≤ ULN in patients with Gilbert's syndrome * AST(SGOT)/ALT(SGPT) ≤ 2.5 × ULN * Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min/1.73 m2 * Resting and ambulatory oxygen saturation ≥ 94% on room air * FEV1 and DLCO (adjusted for Hemoglobin) ≥ 50% predicted * Willigness to use contraception * Ability to understand and the willingness to sign a written informed consent document. Exclusion criteria * Participants who are receiving any other investigational agents after ASCT. * Participants with active CNS involvement are excluded. * History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg/d) are not excluded from this study. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab. Prior hypersensitivity reactions to anti-CD20 therapy or anti-CD30 therapy is not an exclusion criterion. * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Receipt of > 600 mg/m2 total dose of BCNU with prior treatments including transplant conditioning regimen. * Uncontrolled 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 or pose excess risk to the participant in the opinion of the treating clinician.. * Pregnant or lactating women. * HIV-positive. * Participants with active viral hepatitis (positive HepB sAg, positive HepB core Ab with positive HepB viral load, or positive HepC antibody with positive HepC viral load). * Receipt of a live vaccine within 30 days of the start of treatment. Examples are measles, mumps, rubella, varicella, yellow fever, rabies, BCG, oral polio vaccine, and oral typhoid vaccine. * Prior treatment with an anti PD-1, anti PD-L1, or anti CTLA-4 agent. Participants who entered clinical remission with one of those agents and proceeded to ASCT without intervening relapse may be eligible after discussion with the Study Chair. Note that for patients who enter remission with checkpoint blockade therapy, this will not count towards the 3 lines of prior therapy.

Study Objectives The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval. Conditions: Neoplasms, Breast Intervention / Treatment: DRUG: GW572016 oral tablets Location: United States, Israel, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen. * Ability to understand and provide written informed consent to participate in this trial. * Is male or female. * Female and male subjects agree to the protocol specific birth control measures Exclusion Criteria: * Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure. * Is a pregnant or lactating female. * Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations. * Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2). * Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. * Has a left ventricular ejection fraction (LVEF) < 40% based on MUGA or ECHO.

Study Objectives This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with Docetaxel. The purpose of this study is to evaluate the activity of the weekly administration of cabazitaxel as time to progression by PSA at week 12. Conditions: Hormone Refractory Prostate Cancer Intervention / Treatment: DRUG: Cabazitaxel 10 mg/m2 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 who have given written informed consent. * Age ≥ 18 years. * ECOG 0-2. * Patients with a histologic or cytologic diagnosis of advanced prostate cancer (any Gleason grade). * Previous and ongoing castration by orchiectomy or LHRH agonists. Antiandrogen must be discontinued prior to study start. * Disease progression, clinically or radiologically documented, during or after treatment with docetaxel, with a minimum cumulative dose of 225 mg/m2. * "Unfit" patients defined as patients who satisfy at least one of the following criteria: * ECOG 2 * Dose reduction due to febrile neutropenia during the previous treatment with docetaxel * Radiation therapy affecting more than 25% of bone marrow reserve * Documented metastatic disease and progressing after docetaxel treatment. Progression criteria is considered any of the following three or more than one at once: * Progressive elevation of PSA measured in three successive determinations one week difference between them at least; * Should be considered progression of measurable disease by RECIST criteria; * Bone progression as evidenced by the appearance of two or more new lesions on bone scan. * Patients who have received a maximum of one prior chemotherapy for metastatic disease. * Prior anticancer therapy should have been interrupted 28 days before the start of study treatment (the patient may have continued treatment with prednisone 5 mg bid. * Adequate blood, liver and kidney function: * Hemoglobin > 9.0 g/dl * ANC > 1.5 x 10\*9/L * Platelets > 100 x 10\*9/L * AST/SGOT and ALT/SGPT < 2.5 x ULN * Bilirubin < 1.0 x ULN * Creatinine <1.5 mg/dL x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded (see Annex 7 for formula) * Adequate baseline cardiac function (LVEF ≥ 50%). * Life expectancy ≥ 12 weeks. * Patients must agree to use an effective contraceptive method during treatment with the study drug and up to 1 month after ending the treatment. Exclusion Criteria: * Patients who received radiation therapy that exceeded 40% of the bone marrow reserve or that ended within the last 3 weeks prior to inclusion. * If being treated with radiation therapy, should be completed before the three weeks prior to initiation of treatment research. * Previous treatment with two or more chemotherapy regimens for metastatic disease. A new line of treatment is also when a patient receives again docetaxel after clinical, radiological or PSA progression to a prior regimen with docetaxel. * Previous treatment with chemotherapy or surgery in the last 4 weeks. * Peripheral neuropathy or stomatitis ≥ 2 (National Cancer Institute Common Terminology Criteria - NCI CTCAE vs. 4.03). * Any other type of cancer in the last 5 years, except for basal cell skin carcinoma. * Cerebral or leptomeningeal metastasis. * Myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass, congestive heart failure (NYHA class III or IV), stroke or transitory ischemic episodes. * Patients who present any severe or uncontrolled medical condition (including uncontrolled diabetes mellitus) or any other condition that may affect the patient's participation and study compliance. * Previous treatment with cabazitaxel. * Known hypersensitivity (≥ grade 3)to cabazitaxel, polysorbate 80, prednisone or prednisolone, or docetaxel or paclitaxel. * Known history of active infection that requires systemic antibiotic or antifungal treatment. * Patients who are receiving or expect to receive treatment with strong inhibitors or strong inducers of cytochrome CYP450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Annexes 5 and 6). * Patients being treated with any investigational product.

Study Objectives The purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications. Conditions: Advanced Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, SSCHN Intervention / Treatment: DRUG: Docetaxel, DRUG: Cisplatin, DRUG: 5-Fluorouracil Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (SSCHN). * At least one bi- or uni-dimensionally measurable lesion. * Stage II or IV disease without evidence of distant metastasis. * No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN. * Age greater than 18 years. * ECOG performance status of 0 or 1. * Life expectancy of greater than 12 weeks. * Adequate bone marrow, hepatic and renal function. * Normal serum calcium Exclusion Criteria: * Primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands. * Patients with any non-SSCHN malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix. * Any prior treatment with chemotherapy. * Prior radiotherapy to major bone marrow area (> 10% bone marrow) or to head and neck. * Current peripheral neuropathy of greater than NCI grade 2. * Other serious illness or medical condition * Concurrent treatment with corticosteroids unless chronic treatment at low doses. * Pregnant or lactating females or females of childbearing potential not employing adequate contraception.

Study Objectives This randomized phase I trial is studying the side effects and best dose of everolimus, gemcitabine hydrochloride, and cisplatin in treating patients with unresectable solid tumors refractory to standard therapy. Drugs used in chemotherapy, such as everolimus, gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Conditions: Cholangiocarcinoma of the Gallbladder, Localized Gallbladder Cancer, Unresectable Gallbladder Cancer, Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: everolimus, DRUG: gemcitabine hydrochloride, DRUG: cisplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologic proof of cancer that is now unresectable and refractory to or refused all standard treatment for the disease; exception: cancers in which gemcitabine is considered an appropriate initial treatment option * Cohort III (MTD) Only: Patients with histologic proof of metastatic cholangiocarcinoma or gallbladder carcinoma who have not had previous treatment for metastatic disease or who received gemcitabine >= 6 months ago as part of adjuvant therapy * Absolute neutrophil count (ANC) >= 1500/uL * Platelet (PLT) >= 100,000/uL * Total bilirubin =< 1.5 x Institutional upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5x ULN in patients with liver metastases) * Creatinine =< 1.5 x Institutional ULN * Alkaline phosphatase =< 5 x Institutional ULN * Hemoglobin (Hgb) >= 9.0 g/dL * International normalized ratio (INR) and Partial thromboplastin time (PTT) =< 3.0 x ULN (anticoagulation is allowed if target INR =< 3.0 x ULN on a stable dose of warfarin or on a stable dose of low-molecular-weight \[LMW\] heparin for > 2 weeks at time of registration) * Fasting serum glucose < 1.5 x ULN * Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 * Ability to provide informed consent * Willingness to return to Mayo Clinic for follow up * Life expectancy >= 12 weeks * Women of childbearing potential only: Negative serum pregnancy test done =< 7 days prior to registration Exclusion Criteria: * Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy * 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 * Clinically significant cardiac disease, especially history of myocardial infarction =< 6 months, or congestive heart failure (New York Heart Association \[NYHA\] classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Patients taking strong inhibitors or inducers of CYP3A4 * Prior therapy with everolimus * Any of the following prior therapies: * Chemotherapy =< 4 weeks prior to registration * Mitomycin C/nitrosoureas =< 6 weeks prior to registration * Immunotherapy =< 4 weeks prior to registration * Biological therapy =< 4 weeks prior to registration * Radiation therapy =< 4 weeks prior to registration * Radiation to > 25% of bone marrow prior to registration * Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * CNS metastases that are not stable for at least 4 weeks prior to registration based on imaging, clinical assessment, and use of steroids * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive * Current active other malignancy, except non-melanoma skin cancer or carcinoma-in-situ of the cervix * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) * Severely impaired lung function (i.e., forced expiratory volume in one second \[FEV1\] < 1 liter) * Received immunization with attenuated live vaccines =< 7 days prior to study entry or during study period; NOTE: close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus; examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines * Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C); Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection

Study Objectives This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy. Conditions: Non-Hodgkin's Lymphoma, Multiple Myeloma Intervention / Treatment: DRUG: Kepivance (Palifermin) Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: PREVENTION Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Non-Hodgkin's lymphoma (NHL) subjects scheduled to receive BEAM conditioning chemotherapy followed by autologous PBSCT, or multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous PBSCT * ≥Age 18 years * ECOG performance status <= 2. In the MM group, ECOG status >2 will be accepted provided that it is exclusively due to MM (e.g. pathological fracture) * Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) ≥ 60% of predicted * Left ventricular ejection fraction (LVEF) ≥ 50% * Minimum of 1.5 x 10\^6 CD34+ cells/kg for autologous transplantation * Adequate haematological function (ANC ≥ 1.5 x 10\^9/L and platelet count ≥ 100 x 10\^9/L) * Serum creatinine <= 2.0 mg/dL * Total bilirubin <= 2 mg/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 4.0 x IULN * Negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment * Each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication. Exclusion Criteria: * History of or concurrent cancer other than NHL or MM * Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2)- Prior autologous or allogeneic transplants * Oral abnormalities defined as baseline oral assessment of WHO grade >0 * Other investigational procedures are excluded * Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) * Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding * Subject is not using adequate contraceptive precautions * Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) * Subject has known sensitivity to any of the products to be administered during dosing, including E coli-derived products * Subject has previously been treated on this study or with other keratinocyte growth factors * Unwilling or unable to complete the patient-reported outcome questionnaires * Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Study Objectives The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms. Conditions: Brain Edema, Brain Tumor Intervention / Treatment: DRUG: hCRF, DRUG: placebo hCRF Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Histologically confirmed diagnosis of a primary malignant brain tumor or, if metastatic, documentation and histology (if available) of primary source of cancer. * Patient must have 1 or more qualifying steroid-associated side effect(s) at Baseline. * Patient has required administration of dexamethasone to control symptoms of peritumoral edema for at least 30 days. * Stable dexamethasone dose of 4-24 mg/day for at least 14 days prior to Baseline. * Need for administration of dexamethasone to treat peritumoral brain edema (referenced above) has been documented by MRI or comparable diagnostic technology within 21 days of Baseline. * Karnofsky score of > 50 at Screening and Baseline. * Capable of self-administration of subcutaneous injections twice daily for 12 weeks, or availability of assistance from caregiver. * Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent. * For women of childbearing potential: a negative serum pregnancy test at Screening. * Must be 18 years of age or older Exclusion Criteria: * Ongoing or anticipated need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within the first 5 weeks of study enrollment. Treatment with pre-study chemotherapy may continue. * Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the first 5 weeks of treatment. * Systemic steroid use for any indication other than peritumoral brain edema. * Use or intended use of dexamethasone as an anti-emetic during Screening or Study * Non-compliance with dexamethasone or anticonvulsant therapy. * Clinical signs and symptoms of cerebral herniation. * Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation. * Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation. * Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations. (Maintenance anticonvulsant therapy is allowed.) * Central nervous system infection. * Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential. * Any conditions that are considered contraindications for patients to receive niacin, e.g. liver disease (with LFTs > 3 times the upper limit of the norm),active peptic ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.

Study Objectives This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer. Conditions: Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer Intervention / Treatment: DRUG: Cholecalciferol, DRUG: Genistein, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, OTHER: 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: * Participants must have microscopic confirmation of adenocarcinoma of the prostate within three months of randomization; clinical stage T1 and T2 a, b, or c are allowed * Participants' prostate cancer must be confined to the prostate (in the clinical judgment of the treating physician) * Participants must be candidates for prostatectomy * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =<1 (Karnofsky >= 70%) * White blood cell (WBC) within normal limits * Platelets >= 100 K/uL * Hemoglobin >= 10 g/dL * Thyroid-stimulating hormone (TSH) =< 4.20 uIU/mL * Free T4 =< 12.5 ng/dL * Bilirubin within upper limit of normal * Aspartate aminotransferase (AST) =< 1.5 x upper limit of normal * Creatinine =< 2.0 mg/dL * Serum calcium: within institutional normal limits * Participants must agree to stop taking nonsteroidal anti-inflammatory drugs (NSAIDS) during the course of the study, however, low dose aspirin (< 100 mg/day) will be allowed; no wash out period is required * Participants must be willing to discontinue consuming soy products and ingesting vitamin supplements while participating in this study * The effects of cholecalciferol and genistein on the developing human fetus at the recommended therapeutic doses are unknown; for this reason, participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation * Participants must have the ability to understand and sign a consent form indicating the investigational nature of the treatment and its potential risks Exclusion Criteria: * Participants may not have received any prior therapy for prostate cancer including: chemotherapy, hormonal therapy, brachytherapy, or external radiation * Participants may not be receiving concurrent systemic therapy for other cancers * Participants may not be receiving any other investigational agents * Participants may not be taking the following p450 inducers and inhibitors: carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifabutin, rifampin * Participants who took finasteride or dutasteride within 6 months of the pre-randomization biopsy, are currently taking finasteride or dutasteride, or are planning on taking these agents during study participation * Participants with a history of allergic reactions attributed to genistein or placebo, or compounds of similar chemical or biologic composition * Participants with 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 * Participants requires thyroid replacement therapy; Note: participants with a history of thyroid disease > 5 years ago, with current normal thyroid function, will be considered eligible * Participant has current, known nephrolithiasis or a history of nephrolithiasis within the past 5 years * Participant has any history of sarcoidosis

Study Objectives In this study, researchers wanted to learn more about the effect of Aspirin taken as low dose (75 - 300 mg) in preventing stomach, colorectal and esophagus cancer. The researchers were interested in the effect by duration of aspirin use and the effect on the time since aspirin intake has been stopped in preventing stomach, colorectal and esophagus cancer. In addition, the study also looked into the time patients survived after being diagnosed (survival rate) with cancer and number of cancer patients who died (case fatality rate). The study was based on an electronic database managed by the Health Authority in Hong Kong containing anonymized clinical information of patients living in Hong Kong. Conditions: Gastrointestinal Cancer Intervention / Treatment: DRUG: Acetylsalicylic Acid (Aspirin, BAYE4465) Location: Hong Kong Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Received prescription of either low-dose aspirin (75-300 mg) or paracetamol monotherapy during enrolment period. Exclusion Criteria: * Received prescription of aspirin monotherapy or combination one year prior to the index date * Recorded diagnoses of any type of cancer before the index date * Recorded procedures of colectomy, gastrectomy prior to the index date * Age < 40 years

Study Objectives 1. Study Objectives 1) Primary Objective: Progression-free survival 2) Secondary Objectives: 1. overall survival 2. response rate 3. incidence, nature and severity of all adverse events 4. lipid lowering effect of simvastatin 5. exploratory biomarker analysis : angiopoietin 2, BiP (Binding protein), Hsp (Heat shck protein) 90α 2. Study hypothesis In our recent in vitro study, addition of simvastatin to bevacizumab reduced proliferation, migration, invasion and tumor formation of endothelial cell. Moreover, colorectal cancer cell media which was treated with simvastatin combined with bevacizumab inhibited endothelial cell invasion and it was associated with decreased mediator of angiogenesis, such as angiopoietin 2, BiP and HSP 90α.. Treatment with bevacizumab and simvastatin more reduced the growth of xenograft tumors compared with bevacizumab alone. 3. Assessments 1) Safety : physical examination, vital signs, body weight, ECOG (Eastern Cooperative Oncology Group) performance status, clinical laboratory evaluation (chemistry, blood cell count) and any AE (adverse effect) graded by using CTCAE (Common Toxicity Criteria for Adverse Effects ) v 4.0 2) Efficacy : progression-free survival and overall survival will be collected. Response rate according to RECIST (Response Evaluation Criteria in Solid Tumors) 1,1 guideline will also be evaluated 3) PFS (Progression free survival): time from randomization to tumor progression or death 4) OS (Overall survival) : time from randomization to death or last follow-up 5) Biomarker analysis; The correlation between blood level, protein expression of angiopoietin 2, BiP, Hsp90α and clinical response will be explored. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Simvastatin 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-confirmed colorectal carcinoma * Stage IV or recurrent colorectal cancer * age ≥ 20 years * ECOG performance status ≤1 * At least one measurable tumor mass according to RECIST 1.1 * Expected survival for approximately 12 weeks or longer * No prior systemic chemotherapy * At least 4 weeks later after surgery or radiotherapy * At least 12 months after adjuvant chemotherapy Exclusion Criteria: * Prior statins therapy within 1-year from the date of study entry * Prior chemotherapeutic treatment for metastatic colorectal cancer. * Prior other anti-VEGF (vascular endothelial growth factor) or TKIs (Tyrosine kinase inhibitors) treatment * Current, Known CNS(central nervous system) malignancy (history of completely resected or irradiated brain metastases by WBRT (whole-brain radiation therapy) or stereotactic radiosurgery allowed. * Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months(congestive heart failure NYHA (New York Heart Association) III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias) * Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible) * Uncontrolled systemic illness such as DM (diabetes mellitus), hypertension, hypothyroidism and infection * History of thromboembolic or hemorrhagic events within 6 months prior to treatment * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to enrollment. * Evidence of bleeding diathesis or coagulopathy

Study Objectives The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses. Conditions: Breast Cancer, Advanced Malignant Solid Tumors Intervention / Treatment: DRUG: neratinib, DRUG: vinorelbine Location: Netherlands, Spain, United Kingdom, United States, Belgium, Taiwan, Hong Kong, China, Sweden, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1 only) or Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only). * At least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only). * At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Exclusion Criteria: * More than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. Subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only). * Prior treatment with vinorelbine for metastatic setting, or prior treatment with any ErbB-2 targeted agents except trastuzumab (part 2 only). Up to 20 subjects with ErbB-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2. * Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).

Study Objectives The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Icotinib, DRUG: Gefitinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV). * Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =. Exclusion Criteria: * Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.

Study Objectives The purpose of this study is to determine the side effects and best weekly dose of PR104 in patients with advanced solid tumors. Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: PR104 Location: New Zealand Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age 18 years or more * Histologically confirmed malignancy for which no effective therapy exists * Measurable or evaluable disease * ECOG Performance Status of 0 or 1. See Section 15.1 (ECOG performance status) for definition of ECOG Performance Status 0 and 1 * Ability to read, understand and provide written informed consent * If the subject is on systemic steroids, the dose of steroids must be stable for at least two weeks prior to the first dose of PR-104 Exclusion Criteria: * Licensed or investigational anti-cancer therapy (including radiotherapy) within four weeks of the baseline disease assessment (within six weeks for nitrosoureas and Mitomycin C). Subjects on androgen deprivation therapy are allowed on study and may continue to receive androgen deprivation therapy while one study * Prior radiotherapy to more than 25% of bone marrow; prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplants); or prior receipt of more than three chemotherapy regimens * Absolute neutrophil count of < 1.5 x 109/L * Platelet count of < 100 x 109/L * Hemoglobin level of < 90 g/L (or requiring a red blood cell transfusion to maintain hemoglobin > 90 g/L) * Serum bilirubin greater than the upper limit of normal * ALT and AST greater than 2.5 times the upper limit of normal * Serum creatinine less than 1.5 times upper limit of normal * Prothrombin time (PT-INR) or activated partial thromboplastin time (APTT) greater than 1.1 times the upper limit of normal range * Women who are pregnant, breast-feeding or planning to become pregnant during the study * Men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose of study medication. See section 5.11 (Contraceptives) for definition of effective methods of contraception * Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during study participation, including uncontrolled infection or infection requiring a concomitant parenteral antibiotic * Plans for concomitant anti-cancer therapy (excluding androgen deprivation therapy) while on study * Less than four weeks since major surgery * Known to be HIV positive, Hepatitis B sAg positive or Hepatitis C positive with abnormal liver function tests * No known contraindication to single doses of naproxen

Study Objectives The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors. Conditions: Melanoma Intervention / Treatment: BIOLOGICAL: Talimogene Laherparepvec, DRUG: Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) Location: United States, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Previously participated in protocol 005/05 (NCT00769704) and: 1. received the maximum number of talimogene laherparepvec treatment injections or cycles of GM-CSF allowable for that patient on study 005/05, or 2. new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/05. New injectable lesions must have appeared within ≤ 12 months from the End of Treatment visit on the 005/05 study. * In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted \[e.g., those patients who do not have clinically relevant progressive disease (PDr)\]. * Performance status (Eastern Cooperative Oncology Group, ECOG) 0 or 1. * For patients randomized to talimogene laherparepvec only: Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no minimum size for injection. Exclusion Criteria: * Prior Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 toxicity related to talimogene laherparepvec of any organ system (with the exception of injection site reactions, fever and vomiting). * History of Grade 3 fatigue lasting > 1 week while on talimogene laherparepvec treatment. * History of Grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment. * History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other talimogene laherparepvec related non-hematological toxicities while on talimogene laherparepvec treatment that required a dose delay or discontinuation of talimogene laherparepvec therapy. * PDr while participating in study 005/05 * Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial. * At the discretion of the investigator, patient was withdrawn from the 005/05 trial.

Study Objectives This was a Phase 1, open-label, single-center study of CS-1008, an immunoglobulin G subclass 1 (IgG1) humanized monoclonal antibody, in subjects with advanced colorectal carcinoma who had received ≥ 1 prior chemotherapy regimen for metastatic disease. Primary study objectives were to determine the influence of the CS-1008 dose on the biodistribution, pharmacokinetics (PK) and tumor uptake of radiolabeled CS-1008 following a single infusion and following continuous sequential doses of CS-1008. Secondary objectives were to evaluate changes in tumor metabolism, antitumor response, and changes in serum apoptosis biomarkers and tumor response markers following treatment with CS-1008. Conditions: Colorectal Neoplasms Intervention / Treatment: DRUG: CS-1008 Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically proven metastatic colorectal cancer with 1 target lesion ≥ 2 cm and evaluable by gamma camera imaging. If this lesion was previously irradiated, progression must have been documented following radiotherapy. * Received at least 1 prior course of chemotherapy for metastatic disease. * Expected survival of at least 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Age ≥ 18 years old. * Able and willing to give valid written informed consent. * Within the last 1 week prior to first study drug administration, laboratory parameters for vital functions were to be in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which were to be within the ranges specified: * Neutrophil count: ≥ 1.5 x 10\^9/L * Platelet count: ≥ 90 x 10\^9/L * International normalized ratio: ≤ 1.5 * Serum bilirubin: ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤ 2 x ULN (≤ 5 x ULN if liver metastases) * Calculated creatinine clearance (Cockcroft-Gault formula): ≥ 55 mL/min Exclusion Criteria: * Active central nervous system metastases. Definitively treated metastases were allowed if stable for 6 weeks off therapy. * Known immunodeficiency or human immunodeficiency virus positivity. * Serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would have interfered with the ability of the subject to fulfill the study requirements. * Other malignancy, apart from non-melanoma skin cancer, within 3 years prior to first study drug administration, that in the opinion of the Investigator had >10% risk of relapse within 12 months. * Chemotherapy, radiotherapy, or investigational agent within 4 weeks prior to first study drug administration. * Regular corticosteroid, nonsteroidal anti-inflammatory drug (NSAID) (other than paracetamol or low-dose aspirin) or other immunosuppressive treatment within 3 weeks prior to first drug administration. Intermittent dosing of corticosteroid or NSAID was permitted if less than 4 doses within a 3-day period. * Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study. * Lack of availability for clinical follow-up assessments. * Pregnancy or breastfeeding. * Women of childbearing potential: refusal or inability to use effective means of contraception.

Study Objectives This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination. Conditions: Non-small Cell Lung Cancer, Carcinoma, NSCLC Intervention / Treatment: DRUG: Ensartinib, DRUG: Durvalumab 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: * Histologic confirmation of metastatic NSCLC. Subjects must have had confirmed ALK rearrangement as assessed by immunohistochemistry. Subjects may have had prior therapy with ALK inhibitors (other than ensartinib) or been ALK inhibitor naïve. ALK inhibitor naïve subjects were informed of the availability of approved ALK inhibitors. * Measurable disease according to RECIST 1.1, defined as ≥ 1 lesion that could be accurately measured in ≥ 1 dimension (longest diameter to be recorded for non-lymph node lesions, shortest diameter to be recorded for lymph node lesions). Each lesion must have been ≥ 10 mm when measured by computed tomography, magnetic resonance imaging, or caliper measurement by clinical examination or ≥ 20 mm when measured by chest x-ray. * Willing to provide a fresh pre-treatment biopsy; however, if subject was ALK inhibitor naïve, either archival or pre-treatment biopsy was acceptable. * Asymptomatic subjects with surgically treated brain metastases must have been ≥ 14 days post surgery at the time of first dosing, while clinically stable with no requirement for steroids. Asymptomatic subjects with radiation-treated brain metastases may have entered the study immediately after completion of the radiation (and been off steroids, if applicable). Symptomatic subjects (those experiencing headache, seizure etc.), must have been relieved from all symptoms of their central nervous system disease, and must have completed radiation and been off steroids prior to first dosing (anti seizure medicine permitted). * Laboratory parameters for vital functions should have been in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which must have been within the ranges specified, regardless of clinical significance: * Hemoglobin: ≥ 9 g/dL * Neutrophil count: ≥ 1.5 x 10\^9/L * Platelet count: ≥ 100,000/mm\^3 * Serum creatinine: ≤ 1.5 x institutional upper limit of normal (ULN), OR creatinine clearance: ≥ 50 mL/min (by Cockcroft-Gault formula) * Serum total bilirubin: ≤ 1.5 × ULN (except for subjects with Gilbert's syndrome who were allowed after consultation with their physician) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): ≤ 2.5 x ULN * Alkaline phosphatase: ≤ 2.5 x ULN * Eastern Cooperative Oncology Group Performance Status ≤ 2. * Age ≥ 18 years. * Able and willing to provide valid written informed consent. * Able and willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up. * Body weight > 30 kg. Exclusion criteria: * Treatment with an investigational agent within 4 weeks of starting treatment, and any prior drug-related toxicity (except alopecia) should have recovered to Grade 1 or less. * Prior treatment with anti-PD-1, PD-L1 (including durvalumab), or cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), or ensartinib (X-396). * Active, suspected or prior documented autoimmune disease (including but not restricted to inflammatory bowel disease, celiac disease, Wegner's granulomatosis, Hashimoto's thyroiditis, rheumatoid arthritis, systemic lupus, scleroderma and its variants, multiple sclerosis, myasthenia gravis). Vitiligo, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger were permitted. * Subjects with clinically significant cardiovascular disease, including: 1. New York Heart Association Class II or higher congestive heart failure. 2. Myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack within 6 months of start of study drug (Day -28). 3. Clinically significant supraventricular or ventricular arrhythmia. 4. QT interval corrected using Fridericia's formula (QTcF) ≥ 450 ms (male) or QTcF ≥ 470 ms (female). 5. Clinically uncontrolled hypertension. * History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events following prior therapy. * Major surgery within 4 weeks of starting treatment (or scheduled for surgery during the projected course of the study). * Women of child bearing potential who were pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) or nursing. * Female subjects of childbearing potential who were sexually active with a non-sterilized male partner must have used at least one highly effective method of contraception (see table below) from the time of screening and must have agreed to continue using such precautions for 90 days after the final dose of investigational products. Non-sterilized male partners of a female subject must have used male condoms plus spermicide throughout this period. Cessation of birth control after this point should have been discussed with a responsible physician. Not engaging in sexual activity for the total duration of the trial and the drug washout period was an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method were not acceptable methods of birth control. Female subjects should have refrained from breastfeeding throughout the period described above. Females of childbearing potential were defined as those who were not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Females were considered post-menopausal if they had been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements applied: * Females <50 years of age were considered post-menopausal if they had been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they had luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). * Females ≥50 years of age were considered post-menopausal if they had been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year prior to study entry, had chemotherapy-induced menopause with last menses >1 year prior to study entry, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). Non-sterilized male subjects who were sexually active with a female partner of childbearing potential must have used male condoms plus spermicide from screening through 90 days after receipt of the final dose of investigational products. Male subjects were to refrain from sperm donation throughout this period. Female partners (of childbearing potential) of a male subject must have used a highly effective method of contraception (see table below) throughout this period. Cessation of birth control after this point was to be discussed with a responsible physician. Not engaging in sexual activity for the total duration of the trial and the drug washout period was an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method were not acceptable methods of birth control. A highly effective method of contraception was defined as one that resulted in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note that some contraception methods were not considered highly effective (e.g. male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation was not the primary mode of action \[excluding Cerazette/desogestrel which was considered highly effective\]; and triphasic combined oral contraceptive pills). * Subjects who were immunosuppressed, including those with known immunodeficiency. * Active infection including tuberculosis (clinical evaluation that included clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus surface antigen result), hepatitis C, or human immunodeficiency virus (positive 1/2 antibodies). Subjects with a past or resolved hepatitis B virus infection (defined as the presence of hepatitis B core antibody and absence of hepatitis B virus surface antigen) were eligible. Subjects positive for hepatitis C antibody were eligible only if polymerase chain reaction was negative for hepatitis C virus ribonucleic acid. * History of severe allergic reactions to any unknown allergens or components of the study drugs. * Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders). * Mental impairment that may have compromised compliance with the requirements of the study. * Lack of availability for immunological and clinical follow-up assessment. * Inability to swallow or retain oral medication, presence of active gastrointestinal disease or other condition that would have interfered significantly with the absorption, distribution, metabolism, or excretion of ensartinib. * Any condition that, in the clinical judgment of the treating physician, was likely to prevent the subject from complying with any aspect of the protocol or that may have put the subject at unacceptable risk. * History of allogeneic organ transplant. * Subjects must not have donated blood while on study and for at least 90 days following the last durvalumab treatment.

Study Objectives This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the safety and tolerability, Maximum Tolerated Dose and preliminary efficacy of Givinostat in patients with JAK2V617F positive Polycythemia Vera. Part A is the dose finding part while Part B is assessing the preliminary efficacy. Patients will be enrolled either in Part A or Part B and transition from one part to the other is not allowed. Eligible patients for this study will have a confirmed diagnosis of Polycythemia Vera according to the revised World Health Organization criteria. Only if the enrolment in Part A is slow (i.e. \< 5 patients enrolled in 3 months), eligibility for this part of the study may be expanded to all patients with chronic myeloproliferative neoplasms. Study therapy will be administered in 28 day cycles (4 weeks of treatment). Disease response will be evaluated according to the European LeukemiaNet criteria after 3 and 6 cycles (i.e. at weeks 12 and 24, respectively) of treatment with Givinostat for both parts of the study. All phlebotomies performed in the first 3 weeks of treatment will not be counted to assess the clinico-haematological response. The study will last up to a maximum of 24 weeks of treatment. However, after completion of the trial, all patients achieving clinical benefit will be allowed to continue treatment with Givinostat (at the same dose and schedule) in a long-term study. Safety will be monitored at each visit throughout the entire duration of the study. Treatment will be administered on an outpatient basis and patients will be followed regularly with physical and laboratory tests, as specified in the protocol; in case of hospitalization, the treatment will be continued or interrupted according to the Investigators' decision. Conditions: Polycythemia Vera Intervention / Treatment: DRUG: Givinostat Location: Germany, Italy, United Kingdom, France, Poland 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 be able to provide informed consent and be willing to sign an informed consent form; * Patients must have an age ≥18 years; * Patients must have a confirmed diagnosis of Polycythemia Vera according to the revised World Health Organization criteria; * Patients must have mutated Janus Kinase 2 (mutation V617F) positive disease; * Patients must have an active/not controlled disease defined as 1. hematocrit ≥ 45% or hematocrit <45% in need of phlebotomy, and 2. platelet count > 400 x109/L, and 3. white blood cell count > 10 x109/L; * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 in Part A, ECOG performance status ≤ 2 in Part B within 7 days of initiating study drug; * Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours of the first dose of study therapy; * Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential; * Adequate and acceptable organ function within 7 days of initiating study drug; * Willingness and capability to comply with the requirements of the study. Note that if the enrolment in Part A is slow (i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may be expanded to all patients with chronic myeloproliferative neoplasms. In this case, the inclusion criteria 5 will be modified as following only for Part A: * Patients must have an active/not controlled disease defined as: * Essential Thrombocythemia patients: Platelet count > 600 x109/L; * Myelofibrosis patients: no response according to European Myelofibrosis Network criteria. Exclusion Criteria: * Active bacterial or mycotic infection requiring antimicrobial treatment; * Pregnancy or nursing; * A clinically significant corrected QT interval prolongation at baseline; * Use of concomitant medications known to prolong the corrected QT interval; * Clinically significant cardiovascular disease including: 1. Uncontrolled hypertension despite medical treatment, myocardial infarction, unstable angina within 6 months from study start; 2. New York Heart Association Grade II or greater congestive heart failure; 3. History of any cardiac arrhythmia requiring medication (irrespective of its severity); 4. A history of additional risk factors for torsade de pointes; * Known positivity for human immunodeficiency; * Known active hepatitis B virus and/or hepatitis C virus infection; * Platelet count < 100 x109/L within 14 days before enrolment; * Absolute neutrophil count < 1.2x109/L within 14 days before enrolment; * Serum creatinine > 2 times the upper limit of normal; * Total serum bilirubin > 1.5 times the upper limit of normal except in case of Gilbert's disease; * Serum aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 3 times the upper limit of normal; * History of other diseases (including active tumours), metabolic dysfunctions, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications; * Prior treatment with a Janus Kinase 2 or Histone Deacetylase inhibitor or participation in an interventional clinical trial for chronic myeloproliferative neoplasms; * Systemic treatment for chronic myeloproliferative neoplasms other than aspirin/cardio aspirin; * Hydroxyurea within 28 days before enrolment; * Interferon alpha within 14 days before enrolment; * Anagrelide within 7 days before enrolment; * Any other investigational drug or device within 28 days before enrolment; * Patient with known hypersensitivity to the components of study therapy.

Study Objectives This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer. The patients received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24 hours after chemotherapy) each cycle for up to 6 cycles. Conditions: Neutropenia Intervention / Treatment: BIOLOGICAL: F-627 240 μg/kg, BIOLOGICAL: F-627 320 μg/kg Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * 18-75 years old; * Female with breast cancer patients after resection who planned to receive up to 6 cycles of chemotherapy (docetaxol, doxorubicin and cyclophosphamide). * Score 0-1 of East Cooperative Oncology Group (ECOG). * Absolute neutrophil count (ANC) ≥ 2.0 × 109/L, hemoglobin (Hb) ≥ 11.0 g/dl, and platelets (PLT) ≥ 100 × 109/L prior to chemotherapy; * Liver and kidney function tests were within normal range; * Left ventricular ejection fraction (LVEF) > 50%; * Willing to provide written informed consent and to compliant study procedure. Exclusion Criteria: * Pregnancy or lactating women; female with pregnancy potential had positive pregnancy test prior to study treatment. * Expected survival < 12 months. * Patients received radiotherapy within 4 weeks prior to enrollment. * Patients received neoadjuvant chemotherapy prior to the resection for breast cancer. * Patients received bone marrow or hemopoietic stem cell transplantation; * Patient was with malignancy other than breast cancer. * Patients received G-CSF treatment within 6 weeks prior to enrollment. * Patient cann't tolerate the pre-treatment of chemotherapy. * Acute congestive heart failure, myocardial disease, or myocardial infarction diagnosed by clinical, electrocardiography, or any other medical procedure. * Any disease that possibly cause splenomegaly. * Acute infections, chronic active hepatitis B infection within 1 year (except subject with negative hepatitis B antigen prior to enrollment) or history of hepatitis C infection. * Patients with active tuberculosis (TB), or had ever the history of close contact with patients with TB except negative result in tuberculin test; or under TB treatment; or suspected TB by chest X-ray. * Known the positive result of human immunodeficiency virus (HIV) or patients with acquired immune deficiency syndrome (AIDS). * Patients with sickle-cell anemia. * Patients with alcohol abuse or drug addiction that may affect the compliance of the study. * Patients with allergy to proteins extracted from Escherichia coli, G-CSF, or drug excipient. * Patients took other investigational products within 4 weeks prior enrollment. * Patients with diseases or symptoms that may not be suitable to be enrolled in this study based on investigator's judgment.

Study Objectives This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Conditions: Fungal Infection, Hematopoietic and Lymphoid Cell Neoplasm Intervention / Treatment: DRUG: Caspofungin Acetate, DRUG: Fluconazole, OTHER: Laboratory Biomarker Analysis, DRUG: Voriconazole Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age * For centers that will use fluconazole as the antifungal comparator: * Age >= 3 months and < 21 years * For centers that will use voriconazole as the antifungal comparator: * Age >= 2 years and < 21 years * The patient must be undergoing allogeneic HCT from any donor (including matched related) with any stem cell source for any underlying condition * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age * Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/gender as follows: * 0.4 mg/dL (1 month to < 6 months of age) * 0.5 mg/dL (6 months to < 1 year of age) * 0.6 mg/dL (1 to < 2 years of age) * 0.8 mg/dL (2 to < 6 years of age) * 1.0 mg/dL (6 to < 10 years of age) * 1.2 mg/dL (10 to < 13 years of age) * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age) * 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age) * Total bilirubin < 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert's syndrome * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) < 5 x upper limit of normal (ULN) for age * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Within 90 days of enrollment: * Patients with a proven or probable invasive mold infection are not eligible * Patients with an incompletely treated invasive yeast infection are not eligible * Patients with an elevated galactomannan level (>= 0.5 index) within 30 days prior to time of enrollment (if performed) must have a full evaluation for invasive aspergillosis (including a negative chest computed tomography \[CT\] scan) during that time period to be eligible for enrollment * Patients receiving treatment for an IFI are not eligible * Patients with a history of echinocandin or azole hypersensitivity are not eligible * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation * Lactating females are not eligible unless they have agreed not to breastfeed their infants

Study Objectives This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy. Conditions: Diffuse Large B Cell Lymphoma Intervention / Treatment: DRUG: C-CAR066 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The patient volunteered to participate in the study, and signed the Informed Consent * Age 18-75 years old, male or female * Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm) * r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20 * At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis * Adequate organ and bone marrow fuction * No contraindications of apheresis * Expected survival time > 3 months * ECOG scores 0 - 1 Exclusion Criteria: * Have a history of allergy to cellular products * Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard * A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease * Patients with active CNS involvement * Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors * Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed * Live vaccination within 4 weeks before peripheral blood apheresis * HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers * Have a history of alcoholism, drug addiction and mental illness * Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception * Patients with severe fludarabine or cyclophosphamide hypersensitivity * The patient has a history of other primary cancers, except for the following: 1. Non-melanoma such as skin basal cell carcinoma cured by resection 2. Cured carcinoma in situ such as cervical, bladder or breast cancer * The investigators believe that there are other circumstances that are not suitable for the trial

Study Objectives This pilot study will investigate the safety and effect of etanercept in HIV infection by studying HIV replication and immune function (as measured by CD4 counts) in individuals with HIV infection. Conditions: HIV Infections Intervention / Treatment: DRUG: etanercept Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adults greater than 18 years of age with documented HIV infection * Highly active antiretroviral therapy (HAART) regimens as defined by the Department of Health and Human Services guidelines; stable regimens for 12 weeks. * CD4 greater than 200 at time of study enrollment * Stable monitoring labs (hematology survey with differential, ALT, creatinine) * Absolute neutrophil count within normal limits Exclusion Criteria: * AIDS defining illness within the last 6 months * Acute bacterial, viral, or fungal infection within the last 1 month, or history of recurring infections * Women who are pregnant or nursing * Hypersensitivity to etanercept * Previous use of etanercept * Acute malignancy in the last 5 years excluding in situ cervical cancer (CA) and common skin cancers (non melanoma) * History of active or latent tuberculosis * History of demyelinating nerve disease * History of seizure disorder * Latex allergy * Subject has any of the following laboratory values within 30 days of baseline: * hemoglobin concentration < 10.0 g/dl for men and < 9.0 g/dl for women * platelet count < 75,000/mm3 * AST or ALT > 5x upper limit of normal (ULN) * serum creatinine > 2.5x ULN * serum pancreatic amylase > 1.5 ULN * Subject requiring treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferon * Subjects who chronically use any over-the-counter (OTC) or prescription medication (except vitamins) must not change the regimen or switch their medication within 3 days of drug administration and until discharged from the study.

Study Objectives The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow. Conditions: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer Intervention / Treatment: DRUG: AMG 386, DRUG: AMG 386 Placebo, DRUG: Paclitaxel, DRUG: Paclitaxel Location: Canada, Portugal, United States, Greece, France, Malaysia, Poland, Israel, India, Italy, Peru, United Kingdom, South Africa, Russian Federation, Bulgaria, Estonia, Spain, Brazil, Belgium, Slovenia, Latvia, Sweden, Mexico, Chile, Czech Republic, Japan, Korea, Republic of, Romania, Switzerland, Australia, Hong Kong, Croatia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Female 18 years of age or older at the time the written informed consent is obtained * Gynecologic Oncology Group (GOG) Performance Status of 0 or 1 * Life expectancy >= 3 months (per investigator opinion) * Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded) * Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy * Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications * Subjects 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 therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment. * Adequate organ and hematological function * Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted * Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer Exclusion Criteria: * Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers * Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded * Subjects with primary platinum-refractory disease * Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy * Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities * Previous abdominal or pelvic radiotherapy * History of arterial or venous thromboembolism within 12 months prior to randomization * History of clinically significant bleeding within 6 months prior to randomization * History of central nervous system metastasis * Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab) * Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments * Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia * Known active or ongoing infection (except uncomplicated urinary tract infection \[UTI\]) within 14 days prior to randomization * Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor * Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide * Clinically significant cardiovascular disease within 12 months prior to randomization * Major surgery within 28 days prior to randomization or still recovering from prior surgery * Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.

Study Objectives This randomized phase I/II trial studies the side effects and best way to give lyophilized black raspberries in preventing oral cancer in high-risk patients previously diagnosed with stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer. Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from patients receiving lyophilized black raspberries may help doctors learn more about changes that occur in DNA and the effect of lyophilized back raspberries on biomarkers. Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Salivary Gland Squamous Cell Carcinoma, Stage 0 Hypopharyngeal Cancer, Stage 0 Laryngeal Cancer, Stage 0 Lip and Oral Cavity Cancer, Stage 0 Nasopharyngeal Cancer, Stage 0 Oropharyngeal Cancer, Stage 0 Paranasal Sinus and Nasal Cavity Cancer, Stage I Salivary Gland Cancer, Stage I Squamous Cell Carcinoma of the Hypopharynx, Stage I Squamous Cell Carcinoma of the Larynx, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Nasopharynx, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage I Verrucous Carcinoma of the Larynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Salivary Gland Cancer, Stage II Squamous Cell Carcinoma of the Hypopharynx, Stage II Squamous Cell Carcinoma of the Larynx, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Nasopharynx, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage II Verrucous Carcinoma of the Larynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Oral Cavity Squamous Cell Carcinoma, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Nasal Cavity and Paranasal Sinus Cancer, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Oral Cavity Squamous Cell Carcinoma, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Oral Cavity Squamous Cell Carcinoma, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Paranasal Sinus and Nasal Cavity Squamous Cell Carcinoma, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer Intervention / Treatment: OTHER: placebo, OTHER: laboratory biomarker analysis, OTHER: questionnaire administration, DRUG: chemoprevention, DRUG: chemoprevention, OTHER: placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eligible subjects includes all adult HN cancer patients who have been previously diagnosed with Stage 1-4 and in-situ squamous cell carcinoma within the past 36 months (mos); with or without further adjuvant therapy and have been determined to be disease free at the time of consent * Patients must be able to take nutrition/medications orally * Have no prior history of intolerance or allergy to berry or berry-containing products * Patients taking cyclooxygenase (COX)-1/COX-2 inhibitors (Indomethacin, Ibuprofen, celebrex) chronically, herbal supplements, who cannot be taken off the medication/supplement due to their clinical condition are eligible to participate in the study but should document daily doses of these medications in their logbooks Exclusion Criteria: * History of intolerance (including hypersensitivity or allergy) to berry or berry-containing products * Inability to take oral nutrition/liquids or history of aspiration pneumonia * Pregnant women: Although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of lyophilized black raspberries (LBR) administration, then LBR will be discontinued and patient will be removed from the study; we should however emphasize, given this is a food based-study, that risks are likely extremely low even though a participant should become pregnant; as such, we are not recommending active contraception for women, but rather if participants become pregnant, that they notify their study doctor, and that they will likely be removed from study; there are no expected or logical risks if men were to father a child, and as such, no contraception will be recommended for men * Inability to grant informed consent * Strict Vegetarians will be excluded from the study; it was found that consuming one portion per day of fruit or vegetables resulted in a significant decrease in oral cancer incidence; in those persons consuming multiple portions each day, there was a 50% reduction in risk; we assume that strict vegetarians will consume multiple portions each day of foods with chemopreventive activity and therefore inclusion of these individuals would have a negative impact on the study; there are several reports in the literature that herbal or multivitamin/mineral supplements have no effect on oral cancer incidence

Study Objectives The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576). Conditions: Secondary Hyperparathyroidism, Hemodialysis Intervention / Treatment: DRUG: Paricalcitol Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients who completed 12 weeks of Study M10-309 (NCT00667576). Exclusion Criteria: * Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism. * Patients with progressive malignancy or clinically significant hepatic disease. * Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576). * Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).

Study Objectives Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types \[i.e. small cell lung cancer (SCLC) and endometrial cáncer\] and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance. Conditions: Endometrial Adenocarcinomas, Neuroendocrine Tumors, Small-cell Lung Cancer With Less Than 2 Prior Cytotoxic-containing Lines of Therapy Intervention / Treatment: DRUG: lurbinectedin (PM01183), DRUG: Doxorubicin Location: Spain, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Voluntarily written informed consent * Age: between 18 and 75 years (both inclusive). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Cohort of patients with SCLC and endometrial cáncer ECOG PS ≤ 2. * Life expectancy ≥ 3 months. * Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors: 1. Breast cancer 2. Soft-tissue sarcoma 3. Primary bone sarcomas. 4. Gynecologic tumors (endometrial adenocarcinomas, epithelial ovarian cancer...) 5. Hepatocellular carcinoma 6. Gastroenteropancreatic neuroendocrine tumors 7. Small cell lung cancer (SCLC) 8. Gastric cancer 9. Bladder cancer 10. Adenocarcinoma of unknown primary site * At least three weeks since the last anticancer therapy, including radiotherapy * Adequate bone marrow, renal, hepatic, and metabolic function * Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan within normal range (according to institutional standards). * Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment Exclusion Criteria: * Concomitant diseases/conditions: * History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year. * Symptomatic or any uncontrolled arrhythmia * Ongoing chronic alcohol consumption, or cirrhosis * Active uncontrolled infection. * Known human immunodeficiency virus (HIV) infection. * Any other major illness that, in the Investigator's judgment * Brain metastases or leptomeningeal disease involvement. * Men or women of childbearing potential who are not using an effective method of contraception * Patients who have had radiation therapy in more than 35% of the bone marrow. This criterion will not apply to cohort of patients with SCLC and endometrial cáncer. * History of previous bone marrow and/or stem cell transplantation.

Study Objectives This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels. Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure Intervention / Treatment: DRUG: CTA018 Injection Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Body mass index between 18 and 35 * On maintenance hemodialysis three times per week * Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL * Adjusted or total serum calcium value greater than or equal to 8.4 mg/dL and lower than 10.0 mg/dL * Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL * Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL * Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study Exclusion Criteria: * On bisphosphonates for at least three months prior to first dose of Study Drug * Currently taking cytochrome P450 3A inhibitors and/or inducers * Abnormal liver functions

Study Objectives To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment Conditions: Breast Neoplasms Intervention / Treatment: DRUG: BIBW 2992, DRUG: trastuzumab, DRUG: vinorelbine, DRUG: vinorelbine Location: Canada, Portugal, Turkey, Lithuania, Egypt, United States, Taiwan, Austria, Czechia, France, Poland, Sri Lanka, Israel, India, Italy, Netherlands, Peru, United Kingdom, Singapore, Ireland, South Africa, Russian Federation, Belarus, Spain, Brazil, Lebanon, Belgium, Slovenia, China, Latvia, Mexico, Chile, Germany, Japan, Korea, Republic of, Australia, Slovakia, Argentina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * Histologically confirmed diagnosis of HER2-overexpression breast cancer * Stage IV metastatic disease * Must have progressed on one prior trastuzumab treatment * no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line) * Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer * Must have (archived) tumour tissue sample available for central re-assessment of HER2-status * At least one measurable lesion according to RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 . Exclusion criteria: * Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab * Prior treatment with vinorelbine * Known pre-existing interstitial lung disease * Active brain metastases * History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation. * Cardiac left ventricular function with resting ejection fraction of less than 50%. * Patients unable to comply with the protocol. * Any contraindications for therapy with vinorelbine or trastuzumab. * Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs. * Use of any investigational drug within 4 weeks of randomisation. * Inadequate hepatic, renal and haematologic organ function

Study Objectives Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this study was to assess the effects of metformin on menstrual disorders and lipid profile in women with PCOS in bandarabbas. Conditions: Polycystic Ovary Syndrome Intervention / Treatment: DRUG: Metformin, DRUG: Metformin Location: Iran, Islamic Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Women with PCOS Exclusion Criteria: * avoiding to participate in the study

Study Objectives Oral anticancer treatments are increasingly numerous. They represent an additional alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who prefer this route of administration over intravenous treatment. The objective of oral therapies is twofold: to remove the constraints and risks associated with infusions and to allow the patient to follow his treatment at home. However, they have significant adverse effects that may affect patients, who are sometimes at a disadvantage compared to how they are treated, and potentially lead to non-compliance with the consequences. This study will identify the factors associated with non-adherence and determine the impact of this non-adherence in terms of treatment efficacy and tolerance. The aim of this routine care study is to evaluate the adherence to oral anticancer therapies during 3 months. Conditions: Adherence, Patient Intervention / Treatment: OTHER: Drug diary filling Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age> 18 years * Cancer proved histologically. * Patient receiving an initial prescription for oral anticancer therapy, excluding hormone therapy * Illness measurable or assessable by imaging * Patient affiliated to a social security scheme * Patient having been informed of the study * Non-opposition of the patient Exclusion Criteria: * Contraindication to oral treatment * Patient's refusal * Patient under tutelage, curatorship or safeguard of justice * Psychiatric illness and / or condition of the patient compromising understanding of information or conduct of the study

Study Objectives Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate. Conditions: Prostate Cancer Intervention / Treatment: DRUG: risedronate, DRUG: Placebo risedronate oral tablet Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Non-metastatic prostate cancer * Men to receive Gonadotropin-releasing Hormone-agonist therapy Exclusion Criteria: * Other cancers except skin cancer * Evidence of metabolic bone disease * Prior use of bisphosphonates

Study Objectives Camptothecins are a potent class of anticancer drugs that inhibit DNA Topoisomerase I. While seen strictly as cytotoxic compounds, camptothecins are actually also targeted agents, inhibiting DNA-Topoisomerase I (Topo I) cleavable complex. First and second generation cogeners are hampered by a labile α-hydroxy-δ-lactone pharmacophore, which hydrolyzes to yield the inactive carboxylate form of the drug. AR-67 (7-t-butyldimethylsilyl-10-hydroxycamptothecin) is a third generation analog engineered to be stable in blood and highly potent. Its enhanced stability results from two factors: (1) AR-67 is highly lipophilic, partitioning into lipid bilayers, thus protecting it from hydrolysis in the aqueous milieu of the bloodstream, and (2) the 10-hydroxy functionality of the drug effectively ablates the high affinity interactions of the carboxylate drug form with albumin, which has been previously shown to diminish the levels of the active lactone species in the circulation. In a recently completed phase I trial, AR-67 showed over 85% lactone stability at all time points studied, and was well-tolerated with grade 4 thrombocytopenia, neutropenic fever and grade 3 fatigue as dose limiting toxicities. The MTD was established at 7.5 mg/m2/day in a daily times five of a 21 day cycle. Preclinical data indicates that AR-67 may concentrate in tumors for a prolonged period of time, compared to plasma clearance of the drug, a phenomenon which has the potential to improve efficacy and decrease toxicity of this compound. What is not known is the optimal dose and schedule of AR-67 needed to produce high tumor penetration, and modest systemic exposure. This pilot proposal seeks to study AR-67 in a novel dosing schedule and to evaluate the feasibility of performing tumor biopsies to determine the tumor half-life of AR-67 in humans. By using multiple tumor biopsies, as a means to document penetration of tumor tissue by AR-67, and compare that to plasma clearance of the drug, the investigators will establish direct pharmacokinetic evidence that AR-67 "hits the target". The investigators propose that a rigorous evaluation of drug penetration into the tumor should be considered, in addition to the MTD, when determining dose of new experimental compounds. Dose-tumor concentration relationships should be established early in the course of clinical development to provide data for rational selection of the phase-II dose. This pilot study will provide important preliminary data to establish the feasibility of this approach for future study. If successful, tumor half life will be used to develop an optimal biologic dose in a phase I trial using this schedule of AR-67. Optimal biologic dosing could become a new standard for dose escalation studies with this compound and other cytotoxic drugs that have specific biologic targets in the future. Conditions: Solid Malignancies Intervention / Treatment: DRUG: 7-t-butyldimethylsilyl-10-hydroxycamptothecin 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: * Patients must be 18 years of age or greater and have a histologically or cytologically proven solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Patients who have recurred after previous surgery and/or radiation may participate in this trial, although no restriction is placed on the number of prior therapies. Patients must be willing and able to have two core-needle biopsies of their tumor to participate in this trial. * Patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable (based on the assessment of their treating physician) and documented by a stable or improved pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 28 days prior to registration. * Patients may have measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). All disease must be assessed within 28 days prior to registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of measurable disease. * Patients must have progressed after at least one prior chemotherapy and not be candidates for salvage surgery. Prior biologic therapy or prior radiation is permitted; however, at least two weeks must have elapsed since the completion of prior therapy and patients must have recovered from all associated toxicities (due to prior therapy) at the time of registration. * At least three weeks must have elapsed since surgery (thoracic or other major surgeries) and patients must have recovered from all associated toxicities at the time of registration. * Patients must have acceptable organ and marrow function documented within seven days of registration and as defined below: * Leukocytes >3,000/mcL * Absolute neutrophil count >1,500/mcL * Platelets >100,000/mcL * Total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) <2.5 X institutional ULN * Creatinine within normal institutional limits, OR * Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. * Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of <2. * 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 other cancer from which the patient has been disease-free for 3 years. * Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. In order to participate in this trial, women / men of reproductive potential must agree to use an effective contraceptive method (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 should inform her treating physician immediately. Women of childbearing potential must have a negative serum pregnancy test documented within seven days of registration. * Patients must be informed of the investigational nature of this study and must sign and provide a written informed consent in accordance with institutional and federal guidelines. * Patients must have a life expectancy of greater than 12 weeks. * Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of AR-67 will be determined following review of their case by the Principal Investigator. Efforts should be made to switch patients taking drugs that are strong inducers of the enzyme CYP3A4 including anticonvulsants (i.e., phenytoin, phenobarbital, carbamazepine, or primidone) and rifampin OR strong inhibitors of CYP3A4 (clarithromycin, itraconazole, and ketoconazole) to other appropriate medications Exclusion Criteria: * Patients must not have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. * Patients may not be receiving any other investigational agents. * 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. * History of ≥ Grade 3 allergic reactions attributed to compounds of similar chemical or biologic composition to AR-67 (i.e. camptothecins such as irinotecan, topotecan or others of this class of pharmaceuticals). * Patients with prior anaphylactic injection reaction of > Grade 3 to paclitaxel or any other product formulated with Cremophor. * Pregnant women are excluded from this study because AR-67 is a camptothecin 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 AR-67, breastfeeding should be discontinued if the mother is treated with AR-67. * HIV-associated symptoms may preclude accurate assessment of toxicity or response to the treatment and because the primary endpoint of this Phase I trial is toxicity, patients with HIV disease will be ineligible for participation. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AR-67. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and are ineligible for enrollment on this study. * Subjects with leukemia or primary brain tumors are excluded from this study. * Subjects may not receive any of the following medications two weeks prior to, during or two weeks after initiation of AR-67: aprepitant, atazanavir, bacillus of Calmette and Guerin vaccine, carbamazepine, citalopram, ketoconazole, intraconazole, measles virus vaccine, mumps virus vaccine, phenobarbital, phenytoin, poliovirus vaccine, rifabutin, rifampin, rotavirus vaccine, rubella virus vaccine, smallpox vaccine, St John's wort, typhoid vaccine, varicella virus vaccine or yellow fever vaccine.

Study Objectives This is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI regimen \[oxaliplatin (O), xeloda (X) and irinotecan (I)\] and to evaluate for preliminary evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma. The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda) administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid, fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: oxaliplatin, irinotecan, capecitabine Location: Singapore Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients between 21 to 75 years of age * A histopathologically or cytological confirmed diagnosis of locally advanced and/or metastatic PDAC that is unresectable * Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) ver 1.1 criteria * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate hematologic function (neutrophils count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L) * Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN * Adequate renal function (calculated creatinine clearance > 50 mL/min) * Able to give informed consent * Toxicity related to previous radiotherapy or chemotherapy resolved to ≤ Grade 1 Exclusion Criteria: * History of prior malignancy except non-melanoma skin cancer within the last 5yrs * Uncontrolled central nervous system (CNS) metastases or carcinomatous meningitis * Uncontrolled concomitant medical illnesses (e.g. hypertension, myocardial infarct, heart failure, ventricular arrhythmia, diabetes, severe infection) * Major surgery within four weeks prior to study treatment * Patients on chronic immunosuppressive therapy * Pregnant or breast-feeding female patients * On anticoagulant therapy with vitamin K antagonists. * Dose-escalation cohort: * Patients homozygous for uridine diphosphate glucuronosyltransferase (UGT)1A1\*6/\*6 or UGT1A1\*28/\*28 * Previous oxaliplatin or irinotecan chemotherapy * Treatment with any of the following anti-cancer therapies prior to the first dose of OXIRI within the stated timeframes * Cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment. Exception for weekly chemotherapy regimens, where a minimum of 2 week washout from the last dose is required. * Biological therapy (e.g., antibodies) within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks, whichever is shorter, prior to starting study drug * Continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug * 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 shortest) prior to starting study drug * Wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug * Dose-expansion cohort: * Previous chemotherapy or radiotherapy

Study Objectives This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma. Conditions: Follicular Lymphoma Intervention / Treatment: DRUG: HCD122 Location: Canada, Italy, Spain, United States, Belgium, Australia, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization \[REAL/WHO\] classification * Documented CD40+ follicular lymphoma * Measurable lesion * Refractory to rituximab * Prior treatment with at least 1 chemotherapeutic regimen * 18 years or older * WHO Performance Status grade 0, 1, or 2 * Life expectancy > 3 months * Obtained written informed consent Exclusion Criteria: * Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL) * History of another primary malignancy that is currently clinically significant or currently requires active intervention * Prior allogeneic stem cell transplantation * Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration * Impaired cardiac function or clinically significant cardiac disease * History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis * History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment. * Known diagnosis of human immunodeficiency virus (HIV) infection * Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C * Ongoing corticosteroid use (>10 mg/day prednisone or equivalent) * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy. Secondary goals include: * Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment) * Evaluation of quality of life (QoL) in patients stopping TKI * Evaluation of medico-economic impact of stopping TKI * Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log * Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P \> 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (\> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500 Conditions: Chronic Myeloid Leukemia Intervention / Treatment: OTHER: Stopping treatment with TKI Location: Finland, Norway, Germany, Portugal, Netherlands, Denmark, Greece, Czechia, Sweden, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * CML in CP under treatment with TKI in first line or in second line because of toxicity to first line TKI or with TKI in combination * Duration of TKI treatment before enrolment at least 3 years * At least complete molecular remission MR4 * Before inclusion confirmation of CMR4 through a EUTOS-CMR laboratory * Baseline data and documentation on treatment before study entry available * Both sexes but fertile women only if using effective contraceptive * Health insurance coverage * 18 years or older Exclusion Criteria: * Under 18 years old * Hospitalized patients without ability to give informed consent * Adults under law protection or without ability to consent * Previous or planned allogeneic stem cell transplantation

Study Objectives This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5% TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of a chalazion. Conditions: Chalazion Intervention / Treatment: DRUG: SUN-131 1.5% TDS, DRUG: Placebo TDS Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Subjects aged ≥ 6 years of either sex and of any race * Subjects with a diagnosis of a single chalazion * Subjects with chalazion erythema score of ≥ 1 * Normal eyelid function without active signs of eye and eyelid infection in either eye. * Must be willing and able to correctly apply and wear a transdermal patch to the eyelid * Avoid wearing contact lenses in the study eye Exclusion Criteria: * Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues). * History of chalazion incision and curettage in study eyelid. * Multiple chalazia in any one eyelid. * Active ocular or eyelid infection Presence of hordeolum in any one eyelid. * An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied. * Diagnosed with glaucoma in either eye. * History of steroid-induced elevation of IOP. * Female subjects who are pregnant or lactating.