NCT00828594终止1 期
A Phase 1 Open Label/ Phase 2 Randomized, Double-blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar®) in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Maximum tolerated dose of combination RAD001+sorafenib
研究概览
简要总结
Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD)
Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone
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
- •Advanced liver cancer
- •No previous systemic therapy for liver cancer
- •Measurable disease on CT or MRI
- •ECOG 1 or less
- •Child-Pugh A
排除标准
- •Active bleeding during the last 30 days
- •Known history of HIV seropositivity
- •Any severe and/or uncontrolled medical conditions including
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Phase 1: RAD001 plus sorafenib
Experimental
干预措施: RAD001 (Drug)
Phase 1: RAD001 plus sorafenib
Experimental
干预措施: RAD001, sorafenib (Drug)
结局指标
主要结局
Maximum tolerated dose of combination RAD001+sorafenib
时间窗: Until maximum tolerated dose is determined
Time to disease progression assessed when 60 events have been observed
时间窗: Until number of events are reached
次要结局
- Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events(Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity)
- Tumor response(Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity)
- Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis(Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity)
- Overall tumor response (phase 2)(Estimate of 1 year for each patient - Until number of events reached and final analysis)
- Progression Free Survivor, Overall Survivor (phase 2)(Estimate of 1 year for each patient - Until number of events reached and final analysis)
- Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2)(Estimate of 1 year for each patient - Until number of events reached and final analysis)
- Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2)(Estimate of 1 year for each patient - Until number of events reached and final analysis)
- Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2)(Estimate of 1 year for each patient - Until number of events reached and final analysis)
- Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose(Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity)
研究者
研究点 (5)
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