EUCTR2012-001961-33-BE进行中(未招募)不适用
A phase I/II, multicenter, open-label dose finding study of oral CFG920 in patients with metastatic castration-resistant prostate cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 75
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
- •-Confirmed diagnosis of castration resistant prostate cancer
- •-Documented metastases
- •- ECOG performance status 0 or 1
- •-Documented progression following the Prostate Cancer Working Group
- •2 guidelines
- •- Fresh or archived tumor sample
- •- Other protocol-defined inclusion criteria may apply
- •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 57
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •- Impaired cardiac function
- •- Uncontrolled hypertension despire appropriate medical therapy
- •- History of pituitary or adrendal dysfunction
- •- Chronic steriod therapy other than daily use of 10mg prednisone
- •- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral CFG920
- •- Brain metastases that have not been adequately treated
- •- Malignant disease other than that being treated in this study
- •-Laboratory abnormalities as specified in the protocol
- •Other protocol-defined exclusion criteria may apply
研究者
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