NCT01208831已完成1 期
An East Asian Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 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
- 45
- 试验地点
- 1
- 主要终点
- determine maximum tolerated dose of single agent LDE225
研究概览
简要总结
The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.
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
- •confirmed diagnosis of advanced solid tumor (including medulloblastoma and basal cell carcinoma)
- •blood work criteria
排除标准
- •patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
- •positive HIV, hepatitis B or C
- •impaired intestinal function
- •impaired heart function
- •pregnant or breast-feeding women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LDE225
Experimental
干预措施: LDE225 (Drug)
结局指标
主要结局
determine maximum tolerated dose of single agent LDE225
时间窗: 28 day cycles
次要结局
- characterize safety and tolerability(28 day cycles)
- characterize pharmacokinetics (PK) of single and repeated doses of LDE225(28 day cycles)
- assess preliminary anti-tumor activity(28 day cycles)
研究者
研究点 (1)
Loading locations...
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