NCT00059722已完成2 期
A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.
Genzyme, a Sanofi Company44 个研究点 分布在 6 个国家目标入组 160 人开始时间: 2003年5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
- 160
- 试验地点
- 44
- 主要终点
- Primary Outcomes:
研究概览
简要总结
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 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
- Crossover
- 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
- •Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
- •Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC
排除标准
- •Subjects who have received second-line or subsequent chemotherapy
- •Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)
结局指标
主要结局
Primary Outcomes:
Part A
i. Time to progression
ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes
Part B
次要结局
- i. Objective response
- iv. WHO performance status
- iii. Time to death
- Part A
- Part B
- i. Objective response in subjects following treatment with the alternate study treatment
- ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
- iii. WHO performance status in subjects following treatment with the alternate study treatment
- iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment
- Secondary Outcomes:
- ii. Disease control at 8 weeks
- v. QOL and LCS from the FACT-L questionnaire
研究者
研究点 (44)
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