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589e2f5b-9286-465b-8162-bb1549cd5ece | Unit of Measure: percentage of participants 11.1 At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Arm/Group Title: Fulvestrant 250 mg + Loading Dose At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Arm/Group Description: Fulvestrant 250 mg + Loading Dose At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Overall Number of Participants Analyzed: 51 At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Measure Type: Number At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Unit of Measure: percentage of participants 17.6 At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
8275f846-59b6-404d-a6d8-e01335279f1a | Total: 8/24 (33.33%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Restrictive Cardiomyopathy * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Palpitations * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | GERD * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Fever * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Sepsis * 1/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Urinary Tract Infection * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Influenza A * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Dehydration * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Hyponatremia * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Worsening of Hypercalcemia * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
8275f846-59b6-404d-a6d8-e01335279f1a | Bone Pain * 21/24 (4.17%) Less than 1/4 patients in the primary trial experienced adverse events. | 0 |
b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7 | Initial Cohort The both Cohorts of the primary trial receive their treatment via Subcutaneous administration. | 1 |
b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7 | Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms The both Cohorts of the primary trial receive their treatment via Subcutaneous administration. | 1 |
b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7 | Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule The both Cohorts of the primary trial receive their treatment via Subcutaneous administration. | 1 |
b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7 | Escalation Cohort The both Cohorts of the primary trial receive their treatment via Subcutaneous administration. | 1 |
b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7 | Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms The both Cohorts of the primary trial receive their treatment via Subcutaneous administration. | 1 |
b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7 | Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule The both Cohorts of the primary trial receive their treatment via Subcutaneous administration. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol: the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies: the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Anthracyclines, taxanes, and capecitabine. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Ixabepilone in countries where this agent is marketed. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Trastuzumab for Her-2 positive disease. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Hormonal therapy in hormone receptor-positive disease. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Eastern Cooperative Oncology Group (ECOG) performance status </= 2. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Serum creatinine </= 2.0 mg/dL or creatinine clearance >/= 40 mL/min according to Cockcroft and Gault formula. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Absolute neutrophil count >/= 1.5 x 10^9/L, hemoglobin >/= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Total bilirubin </= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase </= 3 x ULN (</= 5 x ULN in case of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Are willing and able to comply with all aspects of the treatment protocol. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Provide written informed consent. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Females, age >/= 18 years. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomised partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol: the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Eligible for any other eribulin study that is open in the same region. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Existing anti-cancer therapy-related toxicities of Grade >/= 2, except that alopecia and Grade 2 neuropathy are acceptable. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | History of congestive heart failure with New York Heart Association Classification >II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Electrocardiogram with QTc interval >/= 500 msec based upon Bazett's formula (QTcB). the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Females who are pregnant (positive B-hCG test) or breastfeeding. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Subject with hypersensitivity to eribulin or any of the excipients. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Subjects with meningeal carcinomatosis. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Subjects who have received any of the following treatments within the specified period before the start of treatment: the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks. the primary trial does not accept patients with grade 1 alopecia. | 1 |
18d9991c-ca96-4bab-93af-77654857a07f | Hormonal therapy within 1 week. the primary trial does not accept patients with grade 1 alopecia. | 1 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: Mammography Only secondary trial: Arm 1 (6 mg Estradiol) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: Mammography Only secondary trial: 6 mg of estradiol daily (2 mg tid). Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: Mammography Only secondary trial: Arm 2 (30 mg Estradiol) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: Mammography Only secondary trial: 30 mg of estradiol. (10 mg tid) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: For this reporting arm, the interpretation and analysis was done with mammography only. secondary trial: Arm 1 (6 mg Estradiol) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: For this reporting arm, the interpretation and analysis was done with mammography only. secondary trial: 6 mg of estradiol daily (2 mg tid). Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: For this reporting arm, the interpretation and analysis was done with mammography only. secondary trial: Arm 2 (30 mg Estradiol) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: For this reporting arm, the interpretation and analysis was done with mammography only. secondary trial: 30 mg of estradiol. (10 mg tid) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: Mammography With Adjunct MBI secondary trial: Arm 1 (6 mg Estradiol) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: Mammography With Adjunct MBI secondary trial: 6 mg of estradiol daily (2 mg tid). Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: Mammography With Adjunct MBI secondary trial: Arm 2 (30 mg Estradiol) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: Mammography With Adjunct MBI secondary trial: 30 mg of estradiol. (10 mg tid) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: For this reporting arm, the interpretation and analysis was done with both mammography and MBI together. secondary trial: Arm 1 (6 mg Estradiol) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: For this reporting arm, the interpretation and analysis was done with both mammography and MBI together. secondary trial: 6 mg of estradiol daily (2 mg tid). Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: For this reporting arm, the interpretation and analysis was done with both mammography and MBI together. secondary trial: Arm 2 (30 mg Estradiol) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
6fb9056d-277c-4dc2-9b45-d7661bb41831 | primary trial: For this reporting arm, the interpretation and analysis was done with both mammography and MBI together. secondary trial: 30 mg of estradiol. (10 mg tid) Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | 0 |
52b23601-2276-4634-96c7-8b6e55596085 | Total: 12/63 (19.05%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
52b23601-2276-4634-96c7-8b6e55596085 | Febrile neutropenia * [1]4/63 (6.35%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
52b23601-2276-4634-96c7-8b6e55596085 | Congestive heart failure * [2]1/63 (1.59%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
52b23601-2276-4634-96c7-8b6e55596085 | Cardiac-ischemia/infarction * 1/63 (1.59%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
52b23601-2276-4634-96c7-8b6e55596085 | Vomiting * [1]1/63 (1.59%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
52b23601-2276-4634-96c7-8b6e55596085 | Acute Pharyngitis * 1/63 (1.59%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
52b23601-2276-4634-96c7-8b6e55596085 | Infection * 3/63 (4.76%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
52b23601-2276-4634-96c7-8b6e55596085 | Neutrophil count decreased * [1]1/63 (1.59%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
52b23601-2276-4634-96c7-8b6e55596085 | Pneumonitis/pulmonary infiltrates * [3]1/63 (1.59%) A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | 1 |
95e05332-4926-4381-90a4-87941269e7bf | Objective Response (OR) More than 5% of the primary trial participants achieved partial response (PR). | 0 |
95e05332-4926-4381-90a4-87941269e7bf | Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria . More than 5% of the primary trial participants achieved partial response (PR). | 0 |
95e05332-4926-4381-90a4-87941269e7bf | Time frame: From first dose of study medication to response measurement, up to 34 month More than 5% of the primary trial participants achieved partial response (PR). | 0 |
95e05332-4926-4381-90a4-87941269e7bf | Arm/Group Title: Afatinib 50 mg More than 5% of the primary trial participants achieved partial response (PR). | 0 |
95e05332-4926-4381-90a4-87941269e7bf | Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity. More than 5% of the primary trial participants achieved partial response (PR). | 0 |
95e05332-4926-4381-90a4-87941269e7bf | Overall Number of Participants Analyzed: 41 More than 5% of the primary trial participants achieved partial response (PR). | 0 |
95e05332-4926-4381-90a4-87941269e7bf | Measure Type: Number More than 5% of the primary trial participants achieved partial response (PR). | 0 |
95e05332-4926-4381-90a4-87941269e7bf | Unit of Measure: Participants 4 More than 5% of the primary trial participants achieved partial response (PR). | 0 |
20d51467-b059-4f39-b636-d32f2dc692da | primary trial: Suramin and Paclitaxel secondary trial: Ipatasertib and Paclitaxel Both the primary trial and the secondary trial at least partly administer their interventions orally. | 0 |
20d51467-b059-4f39-b636-d32f2dc692da | primary trial: Suramin and Paclitaxel secondary trial: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. Both the primary trial and the secondary trial at least partly administer their interventions orally. | 0 |
20d51467-b059-4f39-b636-d32f2dc692da | primary trial: Suramin and Paclitaxel secondary trial: Placebo and Paclitaxel Both the primary trial and the secondary trial at least partly administer their interventions orally. | 0 |
20d51467-b059-4f39-b636-d32f2dc692da | primary trial: Suramin and Paclitaxel secondary trial: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. Both the primary trial and the secondary trial at least partly administer their interventions orally. | 0 |
20d51467-b059-4f39-b636-d32f2dc692da | primary trial: Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin. secondary trial: Ipatasertib and Paclitaxel Both the primary trial and the secondary trial at least partly administer their interventions orally. | 0 |
20d51467-b059-4f39-b636-d32f2dc692da | primary trial: Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin. secondary trial: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. Both the primary trial and the secondary trial at least partly administer their interventions orally. | 0 |
20d51467-b059-4f39-b636-d32f2dc692da | primary trial: Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin. secondary trial: Placebo and Paclitaxel Both the primary trial and the secondary trial at least partly administer their interventions orally. | 0 |
20d51467-b059-4f39-b636-d32f2dc692da | primary trial: Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin. secondary trial: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. Both the primary trial and the secondary trial at least partly administer their interventions orally. | 0 |
15c83d26-f9ba-44cc-a920-6941781cdd8b | Total: 26/69 (37.68%) Neutropenia affected the majority of patients in cohort 1 of the primary trial. | 0 |
15c83d26-f9ba-44cc-a920-6941781cdd8b | Anaemia 2/69 (2.90%) Neutropenia affected the majority of patients in cohort 1 of the primary trial. | 0 |
15c83d26-f9ba-44cc-a920-6941781cdd8b | Febrile neutropenia 3/69 (4.35%) Neutropenia affected the majority of patients in cohort 1 of the primary trial. | 0 |