NCT01663415撤回2 期
A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Radiographic progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Progressive prostate cancer while on androgen deprivation therapy
- •Castrate testosterone level
- •Maintenance of surgical or medical castration for duration of study
- •Radiographically visible metastatic disease
- •Symptomatic from prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Life expectancy >=6 months
排除标准
- •Brain metastases or leptomeningeal disease
- •Prior cytotoxic chemotherapy for prostate cancer
- •Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor
- •History of seizure or condition that may predispose to seizure
- •History of loss of consciousness or transient ischemic attack within 12 months
- •Clinically significant cardiovascular disease
研究组 & 干预措施
Enzalutamide
Experimental
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Radiographic progression free survival (PFS)
时间窗: 26 months
Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2).
次要结局
- Overall survival(26 months)
- Time to PSA progression(26 months)
- Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)(Baseline and 26 months)
- Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D)(Baseline and 26 months)
- Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)(Baseline and 26 months)
- Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs)(26 months)
研究者
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