NCT00468260终止1 期
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies-extension Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
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
- •Participation in study EPO906A2120E1
- •Age ≥ 18 years of age
- •Life expectancy ≥ 3 months
- •Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist
- •Completed all PK sampling in the core study
排除标准
- •Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis
- •Female patients who are pregnant or breast feeding
- •Patients with a severe and/or uncontrolled medical disease
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Safety
Tolerability
Potential activity of patupilone once every 21 days in patients that completed the core study
次要结局
- Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST)
研究者
研究点 (1)
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