NCT00359450终止2 期
A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients
Bristol-Myers Squibb30 个研究点 分布在 8 个国家目标入组 186 人开始时间: 2006年7月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 186
- 试验地点
- 30
- 主要终点
- To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
研究概览
简要总结
BMS-275183 given orally twice weekly to patients pretreated for locally advanced or metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the patients enrolled:
- Cohort I: Patients previously treated with one taxane containing regimen.
- Cohort II: Patients previously treated with a platinum based but non-taxane containing regimen.
- Cohort III: Patients previously treated with both a chemotherapy regimen and one EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound.
Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound. Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Men and women, age >= 18 years
- •Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen.
排除标准
- •Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer
结局指标
主要结局
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
次要结局
- To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population
- Assess the response duration
- Assess the progression free survival time
- Assess the overall survival time
- Assess the pharmacokinetics (PK) of BMS-275183
研究者
研究点 (30)
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