NCT02438007终止3 期
ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 953
- 试验地点
- 115
- 主要终点
- Radiographic Progression-free survival
研究概览
简要总结
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
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
- •Progressive metastatic (M1) disease on androgen deprivation therapy
- •Detectable AR-V7 from circulating tumors (CTCs)
- •ECOG performance status 0 or 1
排除标准
- •Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
- •Prior treatment with chemotherapy for CRPC
研究组 & 干预措施
Galeterone
Experimental
干预措施: Galeterone (Drug)
Enzalutamide
Active Comparator
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Radiographic Progression-free survival
时间窗: ≥ 8 months
次要结局
- Time to Initiation of Cytotoxic Chemotherapy(≥ 8 months)
- Overall Survival(≥ 8 months)
研究者
研究点 (115)
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