NCT00071188已完成2 期
A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Genzyme, a Sanofi Company35 个研究点 分布在 9 个国家开始时间: 2004年2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
- 试验地点
- 35
研究概览
简要总结
The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.
The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.
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
- •Signed informed consent
- •18 years or older
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- •No prior chemotherapy/biological therapy/radiation therapy
- •One or more measurable lesions
- •Life expectancy more than 12 weeks
排除标准
- •Brain metastases or spinal cord compression
- •Currently active skin disease
- •History of significant hemoptysis
- •Abnormal blood chemistry
- •Cardiac abnormalities
- •Recent significant cardiac event
- •Coexisting malignancies
研究者
研究点 (35)
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