An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite
研究概览
简要总结
This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
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
- •18 years of age or older
- •World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
- •Life expectancy of 3 months or more
- •Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist
排除标准
- •Severe and/or uncontrolled medical disease
- •Known diagnosis of human immunodeficiency virus (HIV) infection
- •Presence of any other active or suspected acute or chronic uncontrolled infection
- •Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
- •History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Arm A (Normal liver function)
干预措施: Patupilone/EPO906 (Drug)
Arm B (Mild liver dysfunction)
干预措施: Patupilone/EPO906 (Drug)
Arm C (Moderate liver dysfunction)
干预措施: Patupilone/EPO906 (Drug)
结局指标
主要结局
To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite
时间窗: After completion of the study (approximately 6 weeks from treatment)
To determine the maximum tolerated dose of patupilone in patients with hepatic impairment
时间窗: After completion of the study (approximately 6 weeks from treatment)
次要结局
- To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics(After completion of the study (approximately 6 weeks from treatment))
- Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values(After completion of the study (approximately 6 weeks from treatment))
- To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks(After completion of the study (approximately 6 weeks from treatment))