A Randomized Non-Comparative Multicenter Phase II Study of Everolimus/Sorafenib or Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Objective response
研究概览
简要总结
This is a phase II trial that follows the completion of the phase I UCSF trial of everolimus and sorafenib for Renal Cell Carcinoma (RCC). This trial will be for patients who have not had treatment for RCC before. This trial will have 2/3 patients getting everolimus/sorafenib treatment and 1/3 getting sunitinib, an FDA approved RCC drug. All three drugs are approved for advanced RCC when used individually, the combination of everolimus and sorafenib for RCC is not approved by the FDA.
详细描述
In the phase I study of the combination of everolimus and sorafenib, clinical benefit was observed in patients with no prior systemic therapy. There was no evidence of pharmacokinetic interaction and acceptable toxicity at a dosage of sorafenib of 400 mg twice daily (BID) and everolimus 5 mg daily. Based on these data and the need for more effective front-line therapy for renal cell carcinoma, the plan is to investigate this regimen in patients who have not undergone prior therapy. A sunitinib arm is being included as a concurrent reference to help provide a guideline of an activity level and toxicity that would be meaningful to move forward to a phase III study. Therefore, this study is designed as a non-comparative investigation and patients will be randomized in a 2:1 ratio to everolimus/sorafenib or to sunitinib, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 85 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/Sorafenib
Patients will be stratified by current smoking status (smoker: yes or no0, for each smoking stratum patients will be randomized in a 2:1 ratio
干预措施: Everolimus and sorafenib (Drug)
Sunitinib
- Sunitinib is the concurrent control group
- Patients will be stratified by current smoking status (smoker: yes or no), for each smoking stratum patients will be randomized in a 2:1 ratio
干预措施: Sunitinib monotherapy (Drug)
结局指标
主要结局
Objective response
时间窗: 12-18 weeks
Computerized Tomography Scans (CT) done at Screening and every 2 cycles * For Partial Response (PR) or Complete Response (CR), changes in tumor measurements must be confirmed by repeat studies no less than 4 weeks after the criteria for response are first met (RECIST 1.1 criteria) * For Stable Disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum of 12 weeks after study entry
次要结局
- Safety: combination of everolimus and sorafenib(12-18 weeks)
- Progression-free Survival (PFS)(12-18 weeks)
- Time-to-Progression (TTP)(12-18 weeks)
- Clinical Benefit rate(12-18 weeks)
研究者
Andrea Harzstark
Clinical Professor, UCSF Helen Diller Cancer Center
University of California, San Francisco