NCT00766324已完成2 期
A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer
Nerviano Medical Sciences1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group
研究概览
简要总结
To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.
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
- •Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy
- •Adequate bone marrow, liver and kidney function
排除标准
- •More than one prior chemotherapy line
- •Uncontrolled hypertension
- •Brain or leptomeningeal disease
- •Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months
研究组 & 干预措施
A
Experimental
干预措施: PHA-739358 (Drug)
B
Experimental
干预措施: PHA-739358 (Drug)
结局指标
主要结局
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group
时间窗: within the first three months of treatment
次要结局
- Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit(all cycles)
- Overall safety profile(all cycles)
研究者
研究点 (1)
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终止
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不适用
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已完成
2 期
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进行中（未招募）
1 期
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