PTK787/ZK222584 and RAD001 for Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of vatalanib and everolimus
研究概览
简要总结
RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of vatalanib and everolimus in patients with advanced solid tumors.
- Determine the safety and tolerability of vatalanib and everolimus in patients with advanced solid tumors.
- Evaluate the safety and tolerability of vatalanib and everolimus at the MTD in patients with metastatic renal cell carcinoma (RCC).
Secondary
- Describe the non dose-limiting toxic effects associated with vatalanib and everolimus.
- Describe the pharmacokinetics of vatalanib and everolimus in patients with advanced solid tumors.
- Determine the functional extent of mTOR inhibition by changes in the phosphorylation status of S6K protein in peripheral blood mononuclear cells in patients treated with vatalanib and everolimus.
- Describe any clinical responses seen in patients with metastatic RCC in a dose-expansion cohort treated at the MTD.
- Observe overall survival of RCC patients treated with vatalanib and everolimus.
- Determine the time to progression of patients with RCC treated with vatalanib and everolimus.
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
PTK787, RAD001
PTK787 (vatalinib) 1000 mg daily, RAD001 (everolimus) 5 mg daily
干预措施: RAD001 (everolimus) (Drug)
PTK787, RAD001
PTK787 (vatalinib) 1000 mg daily, RAD001 (everolimus) 5 mg daily
干预措施: PTK787 (vatalanib) (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of vatalanib and everolimus
时间窗: Day 1 - 28
Patients were evaluated on Day 1,14 and 28 for dose limiting toxicities
Safety and tolerability
时间窗: Duration of study treatment
Adverse events were assessed every 14 days for the length of the treatment period.
Safety and tolerability at the MTD in patients with metastatic renal cell carcinoma (RCC)
时间窗: Duration of study treatment
Patients were assessed for adverse events every 14 days while on study treatment
次要结局
- Non dose-limiting toxicity(Duration of study treatment)
- Pharmacokinetics(Day 14 Cycle 1, Day 1 Cycle 2)
- Changes in the phosphorylation status of S6K protein in peripheral blood mononuclear cells(Day 1 and 28)
- Clinical response in patients with metastatic RCC(Duration of treatment)
- Overall survival of patients with RCC(Until death)
- Time to progression of patients with RCC(Duration of study treatment)
研究者
Daniel George, MD
Associate Professor of Medicine
Duke University