NCT00351325终止1 期
A Phase I, Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies
Bristol-Myers Squibb5 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2007年9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
- 45
- 试验地点
- 5
- 主要终点
- To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with 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
- •Good activity level
- •Life expectancy of ≥ 6 months
- •Solid tumor malignancy for which paclitaxel and carboplatin are appropriate
排除标准
- •Major surgery within 4 weeks
- •Any concurrent cancer
- •History of autoimmune diseases
- •Symptomatic bowel obstruction
- •Continued use of steroids
- •Symptomatic brain metastases
- •Current nerve damage in fingers/toes
- •Positive for HIV, hepatitis B/C
- •White blood cells < 3,000
- •Hemoglobin < 9
- •Platelets < 100,000
- •ALT/AST and/or alkaline phosphatase >= 2.5 x ULN
- •Creatine > 1.5
- •Prior BMS-663513
研究组 & 干预措施
dose escalation
Experimental
干预措施: BMS-663513 (Drug)
结局指标
主要结局
To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies
时间窗: throughout the study
次要结局
- Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers.(throughout the study)
- Describe anti-tumor activity(throughout the study)
- Obtain tissue or ascites for exploratory research(throughout the study)
研究者
研究点 (5)
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