NCT00300027终止1 期
A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With 5-Fluorouracil/Leucovorin and Irinotecan or Oxaliplatin for Patients With Advanced or Metastatic Cancer
Bristol-Myers Squibb6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年4月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
研究概览
简要总结
The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good performance status
- •Advanced colorectal, pancreatic, esophageal or gastric cancer
- •Tissue for analyses
- •Adequate bone marrow, hepatic, renal function
- •4-6 weeks since prior therapy
- •Adequate protection for women of child bearing potential (WOCBP)
排除标准
- •Brain metastasis
- •Thromboembolic disease
- •Cardiovascular disease
结局指标
主要结局
Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
Echocardiogram every 2 cycles (q 2 cycles)
次要结局
- Tumor response (q 2 cycles)
- PK parameters (during 1st cycle)
- PD markers (weekly)
- Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)
研究者
研究点 (6)
Loading locations...
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