EUCTR2013-005590-41-NL进行中（未招募）1 期
A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA-1 or -2 mutated Her2 negative advanced breast cancer as first line treatment (REVIVAL study) - Phase I/randomized phase II study of carboplatin-olaparib in BRCA mutated breast cancer
etherlands Cancer Institute0 个研究点目标入组 130 人开始时间: 2014年10月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histological or cytological proof of advanced cancer pre-treated with maximally one line of systemic chemotherapy and any line of hormonal therapy and potentially benefitting from olaparib-carboplatin combination therapy;
- •2.Age >= 18 years;
- •3.Able and willing to give written informed consent;
- •4.WHO performance status of 0, 1 or 2;
- •5.Able and willing to undergo blood sampling for PK and PD analysis;
- •6.Life expectancy > 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
- •7.Evaluable disease according to RECIST 1.1 criteria;
- •8.Minimal acceptable safety laboratory values
- •a.ANC of > 1.5 x 109 /L
- •b.Hemoglobin of at least 5.6 mM
- •c.Platelet count of > 100 x 10^9 /L
- •d.Hepatic function as defined by serum bilirubin < 1.5 x ULN, ASAT and ALAT <2.5 x ULN
- •e.Renal function as defined by serum creatinine < 1.5 x ULN or creatinine clearance > 50 mL/min (by Cockcroft-Gault formula);
- •9.Negative pregnancy test (urine/serum) for female patients with childbearing potential;
- •1.Histological or cytological proof of advanced BRCA1 or -2 mutated HER2 negative breast cancer, without systemic chemotherapy pre-treatment for advanced disease and with any line of hormonal therapy pre-treatment;
- •2.Age >= 18 years;
- •3.Able and willing to give written informed consent;
- •4.WHO performance status of 0, 1 or 2;
- •5.Life expectancy > 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
- •6.Measureable disease according to RECIST 1.1 criteria;
- •7.Minimal acceptable safety laboratory values
- •a.ANC of > 1.5 x 109 /L
- •b.Hemoglobin of at least 5.6 mM
- •c.Platelet count of > 100 x 109 /L
- •d.Hepatic function as defined by serum bilirubin < 1.5 x ULN, ASAT and ALAT < 2.5 x ULN
- •e.Renal function as defined by serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min (by Cockcroft-Gault formula);
- •8.Negative pregnancy test (urine/serum) for female patients with childbearing potential;
- •9.Pretreatment containing an anthracycline and/or taxane in the (neo-)adjuvant setting unless these treatments are not indicated.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy;
- •2.Patients who have received previous treatment with platinum compounds or high dose alkylating agents or a PARP1 inhibitor;
- •3.Any current treatment with drugs that induce or inhibit the CYP450 system : http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm#inVivo or APPENDIX IX
- •4.Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;
- •5.Unreliable contraceptive methods. Women and men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: oral, injected or implanted hormonal methods, intra-uterine devices or systems, condom or other barrier contraceptive measures, sterilization and true abstinence)
- •6.Radiotherapy within the last four weeks prior to receiving the first dose of investigational treatment; except 1x8 Gy for pain palliation then a seven days interval should be maintained;
- •7.Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
- •8.Patients with known active hepatitis B or C;
- •9.Recent myocardial infarction (< six months) or unstable angina;
- •10.Symptomatic brain metastases. If adequately treated with resection and/or irradiation and patients are at least four weeks completely free of symptoms of these metastases and without medication related to these metastases patients could be eligible if all other in- and exclusion criteria are obeyed.
- •11.Known leptomeningeal metastases.
- •12.Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment.
- •1.Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy;
- •2.Patients who have had previous treatment with PARP1-inhibitors, capecitabine, platinum compounds or high dose alkylating agents;
- •3.Treatment of advanced disease with non-hormonal therapy;
- •4.More than two lines of endocrine therapy for advanced disease;
- •5.Pretreatment not containing an anthracycline and/or taxane in the (neo-)adjuvant setting unless these treatments are not indicated
- •6.Any current treatment with drugs that induce or inhibit the CYP 450 system : http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm#inVivo or APPENDIX IX
- •7.DPD deficiency (determined by the DYPD*2A and 2846A>T genotype) if randomized to capecitabine
- •8.Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;
- •9.Unreliable contraceptive methods. Women and men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: oral, injected or implanted hormonal methods, intra-uterine devices or systems, condom or other barrier contraceptive measures, sterilization and true abstinence)
- •10.Radiotherapy within the last four weeks prior to receiving the first dose of investigational treatment; except 1x8 Gy for pain palliation then a seven days interval should be maintaine
研究者
相似试验
已完成
不适用
A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA-1 or -2 mutated Her2 negative advanced breast cancer as first line treatment (REVIVAL study)carcinoma of the breast1008362410006291breast cancerNL-OMON46924Antoni van Leeuwenhoek Ziekenhuis20
已完成
2 期
A Phase II study in patients with Extensive-Stage Small Cell Lung Cancer.CTRI/2009/091/000875Gemin X Pharmaceuticals US Inc Chesterfield ParkwaySuite Malvern PA154
进行中（未招募）
1 期
A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide with or without Obatoclax Administered Every 3 Weeks to Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)Extensive-Stage Small Cell Lung Cancer (ES-SCLC)MedDRA version: 9.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stageEUCTR2008-001679-31-CZGemin X Pharmaceuticals US, Inc.
进行中（未招募）
1 期
A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide with or without Obatoclax Administered Every 3 Weeks to Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)Extensive-Stage Small Cell Lung Cancer (ES-SCLC)MedDRA version: 9.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stageEUCTR2008-001679-31-GBGemin X Pharmaceuticals US, Inc.
进行中（未招募）
不适用
A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide with or without Obatoclax Administered Every 3 Weeks to Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)Extensive-Stage Small Cell Lung Cancer (ES-SCLC)MedDRA version: 9.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stageEUCTR2008-001679-31-BGGemin X Pharmaceuticals US, Inc.196