A Phase II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months
研究概览
简要总结
RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.
详细描述
OBJECTIVES:
Primary
- Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free (complete response [CR], partial response [PR], or stable disease [SD]) at 3 months after treatment with everolimus and imatinib mesylate.
Secondary
- Estimate median time to progression in patients treated with this regimen.
- Determine the proportion of patients whose best overall response are CR, PR, SD, or progressive disease.
- Evaluate the mean and range of the maximum percent reduction in tumor size.
- Describe the toxicities 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 100 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
Everolimus and Imatinib Mesylate
Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
干预措施: Everolimus (Drug)
Everolimus and Imatinib Mesylate
Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months
时间窗: Up to 4 years
Progression-free Survival at 3 Months
时间窗: 3 months post 1st dose
次要结局
- Number of Subjects That Demonstrated a Reduction in Tumor Measurements.(Up to 4 years)
- Median Time to Progression(Time to progression)
- Number of Participants With Adverse Events(Duration of study, Up to 4 years)
研究者
Christopher Ryan
Principal Investigator
OHSU Knight Cancer Institute