NCT00413075已完成1 期
Open Label, Dose Escalation Trial of Oral PXD101 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
- 121
- 试验地点
- 5
- 主要终点
- Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort
研究概览
简要总结
This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors. Doses will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing schedule.
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
oral belinostat
Experimental
干预措施: oral belinostat (Drug)
结局指标
主要结局
Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort
时间窗: throughout the study
次要结局
- Determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels(throughout the study)
- Explore anti-tumor activity(throughout the study)
- Determine the safety, tolerability, and anti-tumor activity of orally administered PXD101 to patients with lymphoma(throughout the trial)
研究者
研究点 (5)
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