EUCTR2014-001162-10-NL进行中(未招募)不适用
An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Hormono-Naïve patients with Metastatic Prostate Cancer who have never before received Androgen Deprivation Therapy. - NA
European Uro- Oncology Group (EUOG)0 个研究点目标入组 60 人开始时间: 2015年4月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Adult metastatic hormone-naïve prostate cancer patients with progressive metastatic disease requiring treatment and who have at least one measurable metastasis on either PET/CT or WB MRI or both.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Previous androgen deprivation therapy / Known or suspected brain metastasis or active leptomeningeal disease / Evidence of clinically relevant liver/kidney disease/bone marrow failure / history of seizure or any condition that may predispose to seizure / history of loss of consciousness or transient ischemic attack within 12 months of enrollment / Contra-indication for MRI (e.g. pacemaker).
研究者
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