A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and After Failure of Docetaxel-based Chemotherapy. Descriptive Assessment of the Circulating Tumor Cells in This Context.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Proportion of patients with some episode of neutropenia classified as grade ≥ 3
研究概览
简要总结
Primary Objective:
- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.
Secondary Objectives:
- PSA response rate;
- Descriptive assessment of CTC (circulating Tumor Cells);
- Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;
- Description of the Health Quality of Life of the patients;
- Incidence of adverse events.
详细描述
Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months
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
- 18 Years 至 —（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
Cabazitaxel
25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3
干预措施: CABAZITAXEL (XRP6258) (Drug)
Cabazitaxel
25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3
干预措施: Prednisone (Drug)
Cabazitaxel
25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3
干预措施: Ciprofloxacin (Drug)
Cabazitaxel
25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3
干预措施: G-CSF (Granulocyte colony-stimulating factor) (Drug)
结局指标
主要结局
Proportion of patients with some episode of neutropenia classified as grade ≥ 3
时间窗: 21 days
次要结局
- Proportion of patients with episode of neutropenia grade ≥3(up to 24 months (every 21 days))
- Rate of febrile neutropenia(up to 24 months (every 21 days))
- Rate of diarrhea grade ≥3(up to 24 months (every 21 days))
- PSA response rate(up to 24 months (every 21 days))
- Circulating Tumor Cells Count (CTC) rate(Day 42, Day 84, Day 126 and End of Treatment)
- Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI)(up to 24 months (every 21 days))
- Number of patients with adverse events(up to 24 months (every 21 days))