EUCTR2011-001298-17-IT进行中（未招募）1 期
Phase II study on ET-743 in BRCA1 and BRCA2 mutation carrie and BRCAness phenotype advanced ovarian cancer patients.
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2012年3月6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
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
- Female
入选标准
- •1. Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have previously received at least two platinum based chemotherapy lines, BRCA mutated or with BRCAness phenotype Definition of BRCAness phenotype: high-grade serous cancers, great initial sensitivity to platinum drugs and retention of platinum-sensitivity through multiple relapses, long history of disease, long survival, long TFIs between relapses (patients with high personal risk factors will be included after doing the analysis for BRCA 1-2 mutation before knowing the results). BRCA 1 and/or BRCA 2 mutation carriers (patients with established mutation will be included, patients with high personal risk factors will be included after doing the analysis before knowing the results) 2.Patients with platinum resistant ovarian cancer, BRCA mutated or with BRCAness phenotype who have previously received at least two previous chemotherapy lines (including platinum rechallenge)3. Patient’s written informed consent before any clinical trial-specific procedure. 4. 18 years-of-age or older. 5. Measurable disease as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 7. Hematologic variables: a. Hemoglobin =9 g/dL b. Absolute neutrophil count (ANC) =1,500/µL, and c. Platelet count =100,000/µL. 8. Serum creatinine = 1.5 mg/dL or creatinine clearance = 30 mL/min 9. Creatinine phosphokinase (CPK) = 2.5 ULN. 10. Hepatic function variables a. Total bilirubin = ULN. b. Total alkaline phosphatase = 2.5 ULN c. AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be =2.5 x ULN. 11. Albumin = 25 g/l. 12. Adequately recovered from the acute toxicity of any prior treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •1. Prior exposure to trabectedin. 2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone. 3. More than two prior chemotherapy lines given in patients with resistant, BRCA mutated, ovarian cancer (including platinum rechallenge). 4. More than 3 prior chemotherapy lines given in patients with partially platinum sensitive, BRCA mutated and/or BRCAness phenotype ovarian cancer recurrences (including platinum rechallenge) 5. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy. 6. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer. 7. Known clinically relevant CNS metastases. 8. Other serious illnesses, such as: • Congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrollment; uncontrolled arterial hypertension or arrhythmias • Psychiatric disorder that prevents compliance with protocol • Active viral hepatitis; or chronic liver disease • Active infection • Any other unstable medical conditions
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