NCT00718562已完成2 期
A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib
研究概览
简要总结
This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.
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
- •Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
- •At least one measurable site of disease on CT/MRI scan
- •Normal organ, electrolyte, and bone marrow function
排除标准
- •Previous treatment with nilotinib or any other drug in this class or other targeted therapy
- •Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
- •Impaired cardiac function
- •Use of coumarin derivatives (i.e. warfarin)
- •Women who are pregnant or lactating
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Nilotinib
Experimental
干预措施: AMN107 (Drug)
结局指标
主要结局
Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib
时间窗: 24 weeks
次要结局
- Safety(24 weeks)
- PK profile(24 weeks)
- DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR)(24 weeks)
研究者
研究点 (1)
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