NCT01110668已完成2 期
Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Previously Treated With Imatinib
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
研究概览
简要总结
This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
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
- 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 GIST that is unresectable and/or metastatic
- •Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose
- •At least one measurable site of disease on CT scan at Visit-2
- •WHO Performance Status of 0, 1 or 2 at Visit-2
- •Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2
排除标准
- •Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.
- •Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks
- •Prior or concomitant malignancies other than GIST
- •Impaired cardiac function at Visit-1 or 2
- •Patients with severe and/or uncontrolled concurrent medical disease
- •Use of therapeutic coumarin derivatives
- •Use of any medications that prolong the QT interval
- •Use of CYP3A4 inhibitors
- •Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery
- •Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Nilotinib
Experimental
干预措施: Nilotinib (Drug)
结局指标
主要结局
To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
时间窗: every 8 weeks
次要结局
- To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.(6 months)
研究者
研究点 (1)
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