NCT00442741撤回1 期
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study
研究概览
简要总结
The purpose of this extension study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patupilone + Midazolam
Experimental
干预措施: Patupilone (Drug)
Patupilone + Omeprazole
Experimental
干预措施: Patupilone + Omeprazole (Drug)
结局指标
主要结局
To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study
次要结局
- Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)
研究者
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