A Phase IB/II Multicenter, Two-Arm, Dose-Escalation Study of Oral AEE788 Administered in Combination With Oral RAD001 on a Continuous Once Daily Dosing Schedule in Adult Patients With First or Second Recurrent or Relapsing Glioblastoma Multiforme
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose and dose-limiting toxicity of AEE788
研究概览
简要总结
RATIONALE: AEE788 and everolimus 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. Giving AEE788 together with everolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of AEE788 when given together with everolimus and to see how well they work in treating patients with recurrent or relapsed glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of AEE788 when administered in combination with 1 of 2 different doses of everolimus in patients with recurrent or relapsed glioblastoma multiforme.
Secondary
- Determine the safety and tolerability of this regimen, including acute and chronic toxic effects, in these patients.
- Determine the single-dose and repeated-dose pharmacokinetic profile of this regimen in these patients.
- Determine, preliminarily, the efficacy of this regimen, in terms of response rate, progression-free survival, and overall survival, in these patients. (Phase II)
- Determine the antiangiogenic effects of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
AEE788 200 mg + RAD001 5 mg
AEE788 200 mg qd, RAD001 5 mg qd
干预措施: AEE788 (Drug)
AEE788 200 mg + RAD001 5 mg
AEE788 200 mg qd, RAD001 5 mg qd
干预措施: everolimus (Drug)
AEE788 150 mg + RAD001 5mg
AEE788 150 mg qd, RAD001 5 mg qod
干预措施: AEE788 (Drug)
AEE788 150 mg + RAD001 5mg
AEE788 150 mg qd, RAD001 5 mg qod
干预措施: everolimus (Drug)
结局指标
主要结局
Maximum tolerated dose and dose-limiting toxicity of AEE788
次要结局
- Safety
- Tolerability
- Single-dose and repeated-dose pharmacokinetic profile
- Efficacy (response rate, progression-free survival, and overall survival)
- Antiangiogenic effects