NCT02822157Unknown2 期
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Overall Objective Response
研究概览
简要总结
This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum
- •At least 1 previous line of chemotherapy
- •Measurable disease
- •Patients have a normal organ and bone marrow function measured within 28 days of randomization
排除标准
- •Primary platinum-refractory disease
- •Known hypersensitivity to olaparib
- •Resting ECG with QTc > 470 msec
- •Concomitant use of known potent CYP3A4 inhibitors
- •Symptomatic uncontrolled brain metastases
- •Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
研究组 & 干预措施
Olaparib
Experimental
olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles
干预措施: Olaparib (Drug)
Chemotherapy
Active Comparator
physician's choice chemotherapy
干预措施: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly (Drug)
结局指标
主要结局
Overall Objective Response
时间窗: 1 year after end inclusion
次要结局
未报告次要终点
研究者
研究点 (1)
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