NCT00056459已完成3 期
A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo
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
- Novartis
- 入组人数
- 1,168
- 试验地点
- 144
- 主要终点
- Progression free survival
研究概览
简要总结
To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment
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
- 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
Oxaliplatin/5-FU/LV and PTK787/ZK 222584
干预措施: Vatalanib (Drug)
2
Placebo Comparator
Oxaliplatin/5-FU/LV and placebo
干预措施: Vatalanib (Drug)
结局指标
主要结局
Progression free survival
时间窗: Throughout duration of study
次要结局
- Time to progression(Throughout duration of study)
- Time to treatment failure(Throughout duration of study)
- Tolerability and safety profile(Throughout duration of study)
- Best overall response rate(Throughout duration of study)
研究者
研究点 (144)
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