S0718: Phase I Study Evaluating The Combination of GW786034 (Pazopanib; NSC-737754; IND-XXXX) and CCI-779 (Temsirolimus; NSC-683864; IND-XXXX) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Safety as assessed by NCI CTCAE v3.0
研究概览
简要总结
RATIONALE: Pazopanib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib may also blocking blood flow to the tumor. Giving pazopanib together with temsirolimus may be an effective treatment for advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when given together with pazopanib in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
- To investigate the safety and feasibility of temsirolimus and pazopanib when given in combination in patients with advanced solid tumors.
- To recommend the maximum tolerated dose of this regimen in these patients.
- To investigate the pharmacokinetics of temsirolimus alone and in combination with pazopanib in these patients.
- To investigate the effects of this regimen on relevant biological markers.
- To preliminarily report objective response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8,15, and 22 and oral pazopanib hydrochloride once daily on days 4-28 in course 1 and days 1-28 in all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are obtained periodically for evaluation of the pharmacokinetics of temsirolimus and pazopanib, plasma and serum angiogenic and cachectic factors (e.g., VEGF, bFGF, PlGF and SDF-1) by enzyme-linked immunosorbent assay, and biological markers in the mTOR/PI3/Akt, Ras/MAPK, VEGFR, PDGFR, and HIF-1 pathways.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
结局指标
主要结局
Safety as assessed by NCI CTCAE v3.0
Feasibility of the drug combination
Maximum tolerated dose of temsirolimus in combination with pazopanib
次要结局
- Pharmacokinetics of temsirolimus alone and in combination with pazopanib
- Relevant biological markers
- Objective response as assessed by RECIST criteria