An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Pharmacokinetic profile of cabazitaxel in study population
研究概览
简要总结
Primary Objective:
- To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel
Secondary Objective:
- To assess the safety of cabazitaxel in patients with various degrees of renal impairment
详细描述
The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first.
Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A
Normal renal function - Cabazitaxel administered once every 3 weeks
干预措施: Cabazitaxel XRP6258 (Drug)
Cohort B
Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks
干预措施: Cabazitaxel XRP6258 (Drug)
Cohort C
Severe renal dysfunction - Cabazitaxel administered once every 3 weeks
干预措施: Cabazitaxel XRP6258 (Drug)
结局指标
主要结局
Pharmacokinetic profile of cabazitaxel in study population
时间窗: Up to day 10
次要结局
- Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters(up to 30 days after the last dosing)