NCT01658527撤回2 期
Phase II Randomized Comparative Trial of TAK-700 (Orteronel) Versus Bicalutamide in Metastatic Prostate Cancer Patients Failing 1st Line Treatment With LHRH Agonists or Surgical Castration.
European Organisation for Research and Treatment of Cancer - EORTC4 个研究点 分布在 1 个国家开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- The primary endpoint of the trial is clinical progression free survival.
研究概览
简要总结
The objective of this randomized phase II open label trial is to determine the anti-tumor activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical progression-free survival in prostate cancer patients who failed 1st line treatment with LHRH (luteinizing hormone-releasing hormone) agonists or surgical castration.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 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
Orteronel, 300 mg twice daily
Experimental
干预措施: Orteronel (Drug)
Bicalutamide 50 mg per day
Active Comparator
干预措施: Bicalutamide (Drug)
结局指标
主要结局
The primary endpoint of the trial is clinical progression free survival.
The primary endpoint of the trial is clinical progression free survival. In this protocol, it is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group 2" and referred to as the "PCWG2" for the setting "delay/prevent" progression.
次要结局
- RECIST (Response Evaluation Criteria In Solid Tumors) response in patients presenting with measurable disease
- Time to PSA (Prostate specific antigen) progression and PSA change from baseline
- Overall survival
- Safety according to Common Terminology Criteria for Adverse Events, version 4.03
- Pain (when an SAE (Serious Adverse Event)) or pain requiring initiation of narcotic analgesia
- Skeletal related events, including requirement to initiate chemotherapy, radiotherapy, cord compression or requirement for surgery to the bone
研究者
研究点 (4)
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