NCT01263886已完成2 期
A Multinational, Randomized, Double Blind, Controlled Phase II Trial of Ombrabulin With Taxane and Platinum Combination Administered Every Three Weeks, in First Line Treatment of Patients Metastatic Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 176
- 试验地点
- 43
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
Primary Objective:
- To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC).
Secondary Objective:
- To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach.
详细描述
Patients will be treated for a maximum of 6 cycles (21 days each), in the absence of unacceptable toxicity or disease progression or consent withdrawal. All patients will be followed for disease progression documentation and for patient status until up to one year after the primary analysis cutoff date.
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 (Participant, Investigator)
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
AVE8062 and combination
Experimental
Day 1: AVE8062
Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin
干预措施: ombrabulin (AVE8062) (Drug)
Placebo
Placebo Comparator
Day 1: placebo
Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin
干预措施: placebo (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: approximately 1.5 years
次要结局
- Overall survival (OS)(approximately 1.5 years)
- Objective response rate (OR)(approximately 1.5 years)
研究者
研究点 (43)
Loading locations...
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