NCT00047840已完成2 期
A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
Genzyme, a Sanofi Company27 个研究点 分布在 3 个国家目标入组 129 人开始时间: 2002年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 27
- 主要终点
- Outcome Progression free survival
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
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
- •Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
- •Failure of first-line platinum-based chemotherapy
排除标准
- •Mixed small cell or non-small-cell histology
- •Bronchoalveolar carcinoma
- •Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
- •Prior treatment with docetaxel
结局指标
主要结局
Outcome Progression free survival
次要结局
- Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
- Objective response rate and duration of response
- QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
- WHO performance status
- Time to death
研究者
研究点 (27)
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