NCT00326586已完成1 期
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- To assess safety and tolerability and to identify a dose for Phase II evaluation
研究概览
简要总结
This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Advanced castration-resistant prostate carcinoma with progressive disease
- •At least 4 weeks must have elapsed from major surgery
- •Patient must be available for follow-up
- •Adequate liver and kidney function
- •Adequate blood values
排除标准
- •Uncontrolled or significant heart disease
- •History of seizures
- •History of head injury, loss of consciousness, or stroke
- •Patients undergoing alcohol withdrawal
- •Any concurrent cancer
- •A serious uncontrolled medical disorder or active infection
- •Inability to swallow tablets
研究组 & 干预措施
1
Experimental
干预措施: AR Antagonist (BMS-641988) (Drug)
结局指标
主要结局
To assess safety and tolerability and to identify a dose for Phase II evaluation
时间窗: during the dose escalation phase
次要结局
- To evaluate pharmacokinetics(throughout the study)
- To describe preliminary evidence of anit-tumor activity(throughout the study)
研究者
研究点 (3)
Loading locations...
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