A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 7
- 主要终点
- Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
This is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma.
详细描述
Sunitinib 50mg daily on 4/2 dose schedule has been established as standard of care (SOC) for advanced renal cell carcinoma (RCC). However, Asian patients in real world experienced grade III/IV adverse events much more than expected. This multi-national, phase II, single arm study is going to explore more on the safety/efficacy and relevant biomarkers on sunitinib 2/1 dose schedule in Asian people with advanced RCC.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced renal cell carcinoma with histology confirmation
- •Grade III/IV AEs happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest
- •ECOG performance status 0 or 1
- •Appropriate vital organ functions
排除标准
- •Prior systemic treatment of mRCC
- •Patients treated with any neoadjuvant or adjuvant systemic therapy
- •Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
- •Allergic history to sunitinib
研究组 & 干预措施
Sunitinib
Sunitinib malate, 12.5mg/capsule, 50mg/day
干预措施: Sunitinib malate (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: 24 months
To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
次要结局
- Objective Response Rate (ORR)(24 months)
- progression free survival (PFS)(24 months)
- patient reported outcome (PRO)(24 months)
研究者
vghtpe user
Chief, Division of General Urology, Department of Urology
Taipei Veterans General Hospital, Taiwan