A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 16
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
- •And/or patients who have discontinued sunitinib treatment at any point due to toxicity
- •Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
- •Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%).
排除标准
- •Patient should be excluded if they have unresolved chronic toxicity grade
- •> 1 and related to prior therapy with sunitinib.
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Sorafenib (Nexavar, BAY43-9006) + Interferon
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
干预措施: Sorafenib (Nexavar, BAY43-9006) + Interferon (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: From start of treatment of the first subject until 14 months later, assessed every 8 weeks
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors \[RECIST\]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.
次要结局
- Response Rate(From start of treatment of the first subject until 14 months later, assessed every 8 Weeks)
- Time to Progression(From start of treatment of the first subject until 14 months later, assessed every 8 Weeks)
- Duration of Response(From start of treatment of the first subject until 14 months later, assessed every 8 Weeks)
- Overall Survival(From start of treatment of the first subject until 14 months later, assessed every 8 Weeks)