An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase I Study With Cabazitaxel Administered as a 1-hour Intravenous Infusion Every 3 Weeks in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 48
- 试验地点
- 21
- 主要终点
- Identification of maximum tolerated dose
研究概览
简要总结
Primary Objective:
- To assess the tolerability at global doses
Secondary Objectives:
- Safety
- Pharmacokinetics
- Efficacy
详细描述
The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after the last cabazitaxel administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 73 Years（Adult, Older Adult）
- 性别
- Male
- 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
Arm 1
Patients will receive cabazitaxel as the dose of corresponded level
1-hour intravenous infusion every 3 weeks plus prednisolone 10 mg orally given daily: Dose Level Cabazitaxel Dose Level -1: 15 mg/m², Level 1: 20 mg/m², Level 2: 25 mg/m²
干预措施: Cabazitaxel (XRP6258) (Drug)
Arm 1
Patients will receive cabazitaxel as the dose of corresponded level
1-hour intravenous infusion every 3 weeks plus prednisolone 10 mg orally given daily: Dose Level Cabazitaxel Dose Level -1: 15 mg/m², Level 1: 20 mg/m², Level 2: 25 mg/m²
干预措施: prednisolone (Drug)
结局指标
主要结局
Identification of maximum tolerated dose
时间窗: up to 18 months
次要结局
- Pharmakokinetic parameters of Cabazitaxel(up to 18 months)
- number of participants with treatment emergent adverse events(up to 18 months)
- Prostate Specific Antigen (PSA) Response(up to 18 months)