A Phase II Trial of Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The aim of the study is to explore a prognostic clinical and molecular biomarker profile in a population of BRCA wild-type recurrent high-grade ovarian cancer patients treated with olaparib as maintenance after response to a platinum based therapy as platinum sensitive recurrence treatment.
详细描述
This is a single arm, open-label Phase 2 study designed to evaluate the effect of maintenance olaparib treatment after response to platinum-based chemotherapy in patients with BRCA wild type platinum sensitive recurrent ovarian cancer. The goal is to identify a clinical and molecular profile able to select a group of patients, treated with olaparib as maintenance, with a favorable prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Olaparib
Olaparib is given orally at the dose of 300 mg bid continually as maintenance therapy after a platinum based chemotherapy
干预措施: Olaparib tablets (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: up to 24 months
as determined by investigator
次要结局
- Progression Free Survival 2(up to 36 months)
- Overall Survival(up to 36 months)
- Response Rate(up to 24 months)
- Worst grade toxicity per patient(evaluated at each cycle every 28 days (during maintenance therapy), up to 30 days after cessation of olaparib)