NCT00326131终止1 期
Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 6 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
- 6
- 试验地点
- 1
- 主要终点
- To assess the Pharmacokinetics, metabolism, and routes and extent of elimination of a single dose of [14C] BMS-275183 over a 10 day period.
研究概览
简要总结
The first purpose of this study is to determine how the body absorbs, metabolizes, and eliminates a single dose of BMS-275183 (labeled with radioactive carbon). Secondly, to measure the levels of BMS-275183 in your blood, study the safety of the drug, and to see what effects it has on your cancer.
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
- •Non-hematological malignancy that has progressed on standard therapy
- •No more that 3 prior chemotherapies given for advanced cancer
- •Adequate renal, hepatic and hematologic function
排除标准
- •Uncontrolled or significant pulmonary or cardiovascular disease
- •Active Brain metastases
- •Inability to swallow capsules
- •Serious uncontrolled medical disorder or active infection
结局指标
主要结局
To assess the Pharmacokinetics, metabolism, and routes and extent of elimination of a single dose of [14C] BMS-275183 over a 10 day period.
次要结局
- To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly
研究者
研究点 (1)
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