A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
- •At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
- •At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.
- •More criteria apply
排除标准
- •Metastatic CNS from RCC.
- •Subjects who discontinued Sutent therapy due specifically to intolerance.
- •Prior systemic therapy for mRCC other than sunitinib.
- •Active ketonuria, secondary to poorly controlled diabetes mellitus
- •More criteria apply
研究组 & 干预措施
1
干预措施: Sorafenib (Drug)
2
干预措施: temsirolimus (Torisel) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline up to 24 Months
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
次要结局
- Progression Free Survival (PFS) by Investigator Assessment(Baseline up to 24 Months)
- Overall Survival (OS)(Baseline to date of death from any cause (up to 24 months))
- Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment(Weeks 12, 24, and 36)
- Percentage of Participants With Tumor Response(Baseline up to 24 Months)
- Duration of Response (DR)(Baseline up to 24 Months)