NCT01106508已完成1 期
A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, 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
- 57
- 试验地点
- 3
- 主要终点
- To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
研究概览
简要总结
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule 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
- •Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma)
- •Protocol defined laboratory parameters
- •Performance status ≤ 2
- •Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy
排除标准
- •History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients)
- •Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea
- •Impairment of cardiac function or significant cardiac disease
- •Pregnant or lactating women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LEQ506
Experimental
干预措施: LEQ506 (Drug)
结局指标
主要结局
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
时间窗: 21 day cycles
次要结局
- To characterize the safety and tolerability of LEQ506 treatment(21 day cycles)
- To characterize the pharmacokinetics of LEQ506(21 day cycles)
- To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples(21 day cycles)
- Tumor response(every 6 weeks)
研究者
研究点 (3)
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