NCT00663832已完成1 期
An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
研究概览
简要总结
This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
LBH589
Experimental
干预措施: LBH589 (i.v. panobinostat) (Drug)
结局指标
主要结局
To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
时间窗: determine if MTD occurs after every 3 - 6 pts
次要结局
- To compare the PK profile of i.v. LBH589 with and without docetaxel(PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase)
- To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC(PK assessment will occur during the first 2 weeks of each pt treatment)
- To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone(PK assessment will occur during the first 2 weeks of each pt treatment)
研究者
研究点 (1)
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