NCT01082809已完成2 期
Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma
详细描述
Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study
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 or cytologically confirmed adenocarcinoma of biliary tract
- •unresectable or metastatic
- •ECOG performance status of 0~2
- •measurable or evaluable lesion per RECIST criteria
- •adequate marrow, hepatic, renal and cardiac functions
- •One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
- •provision of a signed written informed consent
排除标准
- •severe co-morbid illness and/or active infections
- •pregnant or lactating women
- •active CNS metastases not controllable with radiotherapy or corticosteroids
- •known history of hypersensitivity to study drugs
研究组 & 干预措施
Sunitinib
No Intervention
Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle
干预措施: Sunitinib (Drug)
结局指标
主要结局
Time to progression
时间窗: 12months
次要结局
- Safety profile(12 months)
- Response rate(12 months)
- Duration of response(12 months)
- Overall survival(12 months)
- Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations(12 months)
研究者
Ho Yeong Lim
Samsung Medical center
Samsung Medical Center
研究点 (1)
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