A Phase I Trial of Weekly and Every Three Weeks Ixabepilone and Sunitinib in Solid Tumor Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and toxicity profile as assessed by NCI CTCAE version 3.0
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone when given together with sunitinib malate in treating patients with progressive advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- To determine the safety and toxicity profile of ixabepilone in combination with sunitinib malate in patients with progressive, advanced non-hematologic malignancies.
- To determine the recommended phase II dose of ixabepilone given weekly versus once every three weeks in combination with a fixed dose of sunitinib malate in these patients.
Secondary
- To evaluate the pharmacokinetic profiles of the combination of ixabepilone and sunitinib malate and correlate them with activity and/or toxicity.
- To obtain preliminary efficacy data (complete response, partial response, or stable disease) of these treatment combinations.
- To correlate changes in angiogenesis biomarkers with clinical (safety and efficacy) and pharmacokinetic parameters in patients treated with these drug combinations.
- To estimate the optimal biological dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
Schedule A
Schedule A: Ixabepilone - Weekly for 3 weeks each cycle (Days 1, 8 and 15) For both Schedules A and B, Sunitinib daily, orally, starting on Day 8 of Cycle 1
干预措施: Ixabepilone (Drug)
Schedule A
Schedule A: Ixabepilone - Weekly for 3 weeks each cycle (Days 1, 8 and 15) For both Schedules A and B, Sunitinib daily, orally, starting on Day 8 of Cycle 1
干预措施: Sunitinib (Drug)
Schedule B
Ixabepilone - Day 1 of each 3-week cycle For both Schedules A and B, Sunitinib daily, orally, starting on Day 8 of Cycle 1.
干预措施: Ixabepilone (Drug)
Schedule B
Ixabepilone - Day 1 of each 3-week cycle For both Schedules A and B, Sunitinib daily, orally, starting on Day 8 of Cycle 1.
干预措施: Sunitinib (Drug)
结局指标
主要结局
Safety and toxicity profile as assessed by NCI CTCAE version 3.0
时间窗: Approximately 18-30 months
Recommended Phase II dose of Ixabepilone when administered with Sunitinib
时间窗: Schedule A (12 - 18 months); Schedule B (6 -12 months after Schedule A)
次要结局
- Correlation of changes in angiogenesis biomarkers with clinical (safety and efficacy) and pharmacokinetic parameters(Approximately 18-30 months)
- Estimation of optimal biological dose(Approximately 18-30 months)
- Pharmacokinetic profiles of Ixabepilone and Sunitinib malate and correlation with activity and/or toxicity(Approximately 18-30 months)
- Efficacy data (complete response, partial response, or stable disease) of these treatment combinations(Approximately 18-30 months)
研究者
Jaime Merchan
Associate Professor
University of Miami