A Phase I/II Trial of an Oral MTOR Protein Kinase Inhibitor (Everolimus, RAD001) in Combination With an Oral EGFR Tyrosine Kinase Inhibitor (Erlotinib, Tarceva™) In Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Anti-tumor activity of RAD001 in combination with erlotinib (Phase II)
研究概览
简要总结
RATIONALE: Erlotinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib together with everolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving erlotinib together with everolimus and to see how well it works in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the safety of everolimus given in combination with erlotinib hydrochloride in patients with metastatic breast cancer (phase I).
- To determine the antitumor activity of the combination (phase II).
- Determine the rate of clinical benefit (complete response + partial response + stable disease for at least 6 months) in patients with metastatic breast cancer (phase II).
Secondary
- To determine the time to progression.
- To determine PTEN, pAkt, pP70S6K1 and pEGFR in primary tumors at baseline.
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
Erlotinib/RAD001 Ph I
Tarceva (OSI-774; erlotinib) Everolimus (RAD001)
Study did not progress to Phase II:
Experimental: Erlotinib/RAD001 Phase II Maximum tolerated dose of erlotinib (Tarceva,OSI-774) and RAD001 (Everolimus)
干预措施: erlotinib (Drug)
Erlotinib/RAD001 Ph I
Tarceva (OSI-774; erlotinib) Everolimus (RAD001)
Study did not progress to Phase II:
Experimental: Erlotinib/RAD001 Phase II Maximum tolerated dose of erlotinib (Tarceva,OSI-774) and RAD001 (Everolimus)
干预措施: RAD001 (Drug)
结局指标
主要结局
Anti-tumor activity of RAD001 in combination with erlotinib (Phase II)
时间窗: at 6 months
Clinical benefit based upon number of patients with complete response (CR), partial response (PR), and stable disease (SD). Responses are determined by Response Evaluation in Solid Tumors (RECIST)criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
To determine the maximum tolerated dose (MTD) of RAD001 given in combination with erlotinib (Phase I)
时间窗: at 4 weeks
MTD will be the dose level at which fewer than 2 of 6 (or 33% of) patients experience dose limiting toxicity (DLT), starting at first 4 weeks.
次要结局
- Time to progression (Phase II)(from study entry to disease progression)
研究者
Ingrid Mayer, MD
Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center