NCT00388557已完成1 期
Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2005年10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
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To assess the effect of ketoconazole on the pharmacokinetics of vinflunine in patient with advanced cancer. A total of 28 blood samples will be collected
研究概览
简要总结
The purpose of the study is to test how ketoconazole affects with handling of vinflunine by the body which might affect how much vinflunine is in the blood stream and for how long
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
- •Advanced cancer excluding cancer within the blood, adequate kidney and liver function.
排除标准
- •Prior use of vinflunine, other active medical disorders, severe nerve damage
研究组 & 干预措施
1
Experimental
干预措施: vinflunine + ketaconazole (Drug)
结局指标
主要结局
To assess the effect of ketoconazole on the pharmacokinetics of vinflunine in patient with advanced cancer. A total of 28 blood samples will be collected
时间窗: Days 1 through 5 and Day 8 of Cycles 1 and 2
次要结局
- Evaluate the safety of vinflunine co-administered with ketoconazole and assess the safety of vinflunine in patients with advanced cancer. Safety laboratory assessments and evaluations will be collected(weekly)
研究者
研究点 (1)
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