NCT02418624已完成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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
A phase I trial to determine the recommended phase two dose of the combination of carboplatin and olaparib.
详细描述
A 3+3 dose escalation trial of 2 cycles (21 days) carboplatin and olaparib combination therapy, followed by olaparib monotherapy until progression or unacceptable toxicity in patients with advanced cancer.
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
- All
- 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
Dose escalation
Experimental
carboplatin, olaparib
干预措施: carboplatin, olaparib (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: per doselevel of 3 to 6 patients (when 3-6 patients have completed DLT period of 3 weeks)
The dose level at which more than 1/6 patients develop a dose limiting toxicity
次要结局
- Pharmacodynamics (PAR (Poly(ADP) ribose) activation measured with the PAR assay)(1 year)
- Objective Response Rate(1 year)
- Pharmacokinetics (area under time-concentration curve (AUC))(1 year)
研究者
研究点 (1)
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