NCT00461110终止1 期
A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •NSCLC who are eligible to receive a 6 week course of RT
- •Part 1 - not candidates for definitive RT
- •Part 2 - candidates for definitive RT
排除标准
- •Severe COPD, pulmonary infection or interstitial pneumonitis
- •Recent cellulitis
- •Autoimmune disease
研究组 & 干预措施
1
Experimental
Active
干预措施: BMS-663513 (Drug)
2
Experimental
Active
干预措施: BMS-663513 (Drug)
结局指标
主要结局
To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma
时间窗: throughout the study
次要结局
- Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers(end of study)
- Describe anti-tumor activity(throughout the study)
- Obtain archival tissue for predictive marker research(at screening)
- Obtain blood and plasma for exploratory research(several timepoints throughout the study)
研究者
研究点 (4)
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