NCT00535951已完成1 期
A Phase IB, Open-Label, Multicenter Study to Investigate the Effect of Oral LBH589 on Dextromethorphan, a CYP2D6 Substrate, 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
- 18
- 试验地点
- 5
- 主要终点
- Pharmacokinetic (PK) parameters
研究概览
简要总结
This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients
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
Pharmacokinetic (PK) parameters
时间窗: first 10 days
次要结局
- Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation(first 10 days, day 10 through end of treatment plus follow-up)
- Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs)(day 10 through end of treatment)
- Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation(day 10 through end of treatment)
研究者
研究点 (5)
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