A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose of imatinib mesylate in combination with sunitinib malate
研究概览
简要总结
RATIONALE: Imatinib mesylate and sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate given together with sunitinib in treating patients with gastrointestinal stromal tumors.
详细描述
OBJECTIVES:
- To determine the maximum tolerated dose of imatinib mesylate in combination with sunitinib malate in patients with gastrointestinal stromal tumors.
- To determine the toxicity of this regimen in these patients.
- To determine the antitumor activity in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral sunitinib malate once daily on days 1-14 in course 1 and on days 1-42 in all subsequent courses. Beginning in course 2, patients also receive oral imatinib mesylate once or twice daily on days 1-42. Courses repeat every 6 weeks in the absence of unacceptable toxicity.
Blood samples are collected on day 15 and day 43 for pharmacokinetics.
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
Therapeutic Intervention
干预措施: imatinib mesylate (Drug)
Therapeutic Intervention
干预措施: sunitinib malate (Drug)
Therapeutic Intervention
干预措施: pharmacological study (Other)
结局指标
主要结局
Maximum tolerated dose of imatinib mesylate in combination with sunitinib malate
时间窗: at 6 weeks
次要结局
- Toxicity profile as assessed by NCI CTCAE v3.0(every 6 weeks)
- Pharmacokinetics(days 15 & 43)
- Preliminary data on anti-tumor activity of these drugs as assessed by RECIST(18 weeks)
研究者
Jordan Berlin
Professor of Medicine; Clinical Director, GI Oncology Program; Director, Phase I Program; Medical Director, Clinical Trials Shared Resources; Medical Oncologist
Vanderbilt-Ingram Cancer Center