A Phase 2, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 154
- 试验地点
- 38
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Primary Objective:
- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin.
Secondary Objectives:
- To compare the overall survival (OS) between the 2 treatment arms
- To compare the objective response rate (RR) between the 2 treatment arms
详细描述
Treatment will continue until disease progression or unacceptable toxicity or consent withdrawal. A minimum of 6 cycles of the combined therapies should be administered, unless progression occurs before or safety reasons cause the discontinuation of one or two drugs of the combination therapies. In case of no progression, it will be investigator's decision to continue or not the study treatment after 6 cycles according to his clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
Arm A
Ombrabulin, Paclitaxel and Carboplatin
干预措施: Ombrabulin (AVE8062) (Drug)
Arm A
Ombrabulin, Paclitaxel and Carboplatin
干预措施: Paclitaxel (Drug)
Arm A
Ombrabulin, Paclitaxel and Carboplatin
干预措施: Carboplatin (Drug)
Arm B
Placebo, Paclitaxel and Carboplatin
干预措施: Placebo (Drug)
Arm B
Placebo, Paclitaxel and Carboplatin
干预措施: Paclitaxel (Drug)
Arm B
Placebo, Paclitaxel and Carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: approximately 24 months
次要结局
- Overall Survival (OS)(approximately 24 months)
- Objective Response Rate (RR)(approximately 24 months)