NCT02074137已完成4 期
Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Number of patients with Related Serious Adverse Events
研究概览
简要总结
Primary Objective:
To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer
Secondary Objectives:
- To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer
- To describe patient profile in terms of demography, disease characteristics and prior treatment history
- To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response
详细描述
The study consists of:
- a screening phase (maximum length of 7-day).
- a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent.
- a 30-day follow-up visit after the last dose of study medication.
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
Experimental
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
干预措施: CABAZITAXEL XRP6258 (Drug)
Cabazitaxel
Experimental
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
干预措施: Prednisone (Drug)
Cabazitaxel
Experimental
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
干预措施: Prednisolone (Drug)
结局指标
主要结局
Number of patients with Related Serious Adverse Events
时间窗: up to13 months
次要结局
- Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications(up to 13 months)
- Radiological overall response (if radiological tumor assessment done) using Recist criteria(up to 13 months)
- Number of patients with at least 50% decrease in PSA(up to 13 months)
研究者
研究点 (3)
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