NCT00534807撤回1 期
Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer
Bristol-Myers Squibb2 个研究点 分布在 1 个国家开始时间: 2007年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements
研究概览
简要总结
The purpose of this study is to test how vinflunine interacts with rifampin in the human body
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
- •Cancer unresponsive to previous treatment
- •Consent for genetic samples
排除标准
- •Cancer of the blood
- •Spread of cancer to the brain
- •Moderate or severe nerve damage
- •Low white blood cell counts and platelet counts
- •Inadequate liver or kidney function
- •Prior treatment with vinflunine
- •Use of certain medications that might interfere with the metabolism of vinflunine
结局指标
主要结局
The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements
时间窗: taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment
次要结局
- The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampin(determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment)
研究者
研究点 (2)
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