NCT00291005已完成2 期
A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
研究概览
简要总结
- To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
- To evaluate PSA (tumor marker) response rate
- To evaluate safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.
排除标准
- •1.Body temperature > 38 degree centigrade.
- •2.Prior radiotherapy to > 25% of bone marrow.
- •3.Prior isotope therapy and/or brachytherapy
- •4.Prior gene therapy.
- •5.Active double cancer.
- •6.Known brain or leptomeningeal involvement.
- •7.History of hypersensitivity reaction to drug
- •8.Other serious illness or medical condition
- •9.Subjects whom the investigators consider inappropriate from social or medical aspects.
结局指标
主要结局
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
次要结局
- Overall response rate by modified WHO criteria, PSA response rate, safety
研究者
研究点 (1)
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