NCT00386555撤回2 期
Phase 2 Study of CP-868,596 + Docetaxel, AG-013736 + Docetaxel, or CP-868,596 + AG-013736 + Docetaxel and of Docetaxel Alone in Patients With Stage IIIb or IV Non-Small Cell Lung Cancer.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Determine the anti-tumor efficacy of CP 868,596 plus docetaxel, AG 013736 plus docetaxel, CP 868,596 plus AG 013736 plus docetaxel, and docetaxel alone in patients with advanced NSCLC based on objective tumor response (CR and PR) rate
研究概览
简要总结
To determine the effectiveness of CP-868,596 + docetaxel, AG-013736 + docetaxel and CP-868,596 + AG-013736 + docetaxel in patients previously treated for non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Platinum-pretreated patients with advanced stage IIIb or IV NSCLC
排除标准
- •Centrally-located tumors
结局指标
主要结局
Determine the anti-tumor efficacy of CP 868,596 plus docetaxel, AG 013736 plus docetaxel, CP 868,596 plus AG 013736 plus docetaxel, and docetaxel alone in patients with advanced NSCLC based on objective tumor response (CR and PR) rate
次要结局
- Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule
- Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule
- Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule
- Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)
- Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel
- Evaluate the PK of CP 868,596 when given in combination with docetaxel
- Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373
研究者
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