Phase 1 Study of the Combination of BAY 43-9006 (Sorafenib) and CCI-779 (Temsirolimus) in Patients With Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Objective response rate (complete response and partial response) CCI-779 in combination with BAY43-9006 (Phase II)
研究概览
简要总结
This phase I trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temosirolimus may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of temsirolimus when administered with sorafenib in patients with metastatic, recurrent, or unresectable melanoma.
II. To determine the safety and toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To Determine the population pharmacokinetics of this regimen in these patients.
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
Arm 1
Patients receive temsirolimus IV over 30 minutes on days 1, 8,15, and 22 and oral sorafenib once or twice daily on days 1-28.
干预措施: sorafenib tosylate (Drug)
Arm 1
Patients receive temsirolimus IV over 30 minutes on days 1, 8,15, and 22 and oral sorafenib once or twice daily on days 1-28.
干预措施: temsirolimus (Drug)
结局指标
主要结局
Objective response rate (complete response and partial response) CCI-779 in combination with BAY43-9006 (Phase II)
时间窗: Up to 5 years
Maximum tolerated dose of CCI-779 in combination with BAY43-9006 (Phase I) determined by DLT assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
时间窗: 28 days
次要结局
- Progression-free survival(The duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress, assessed up to 5 years)
- Overall survival(5 years)
- Noncompartmental pharmacokinetic parameters of BAY43-9006 and CCI-779 estimated using a validated commercial software(Week 1 and 3)