A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects
研究概览
简要总结
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
详细描述
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort
干预措施: Elesclomol Sodium (Drug)
Cohort
干预措施: Docetaxel (Drug)
结局指标
主要结局
To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects
时间窗: Jan 2011
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
时间窗: Jan 2011
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population
时间窗: Jan 2011
次要结局
- To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer(Jan 2011)
- Evaluate OS(Jan 2011)
- To characterize the pharmacokinetics of elesclomol metabolites(Jan 2011)