NCT00503451已完成1 期
A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.
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
- 14
- 试验地点
- 2
- 主要终点
- Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
研究概览
简要总结
The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.
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
- All
- 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 (Drug)
结局指标
主要结局
Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
时间窗: 2 weeks
次要结局
- Safety, tolerability and efficacy of oral LBH589 throughout the study(at least every 2 months)
研究者
研究点 (2)
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