NCT00699517已完成3 期
A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 355
- 试验地点
- 45
- 主要终点
- Progression free survival
研究概览
简要总结
The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms
The secondary objectives of the study are :
- To compare the overall survival in the 2 treatment arms
- To compare the objective response rate in the 2 treatment arms
- To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
- To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
1
Experimental
干预措施: OMBRABULIN (AVE8062) (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Progression free survival
时间窗: until event or study cut-off date (Tumor assessment every 6 weeks)
次要结局
- Overall survival(until event or study cut-off date)
- Response rate(tumor assessment every 6 weeks)
- Safety profile(assessment every 3 weeks)
研究者
研究点 (45)
Loading locations...
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