NCT00785785已完成3 期
A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 644
- 试验地点
- 29
- 主要终点
- Time to Progression Free Survival (PFS)
研究概览
简要总结
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 which is unresectable and/or metastatic and either:
- •have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
- •recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
- •At least one measurable site of disease on CT/MRI scan
- •Performance status ≤ 2 (capable of self-care but unable to carry out any work)
- •Normal organ, electrolyte and marrow function
排除标准
- •Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
- •Disease progression during adjuvant therapy with imatinib
- •History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
- •Impaired cardiac function
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Nilotinib
Experimental
nilotinib 400 mg twice a day
干预措施: Nilotinib (AMN107) (Drug)
Imatinib
Active Comparator
imatinib 400 mg once daily
干预措施: imatinib (STI571) (Drug)
结局指标
主要结局
Time to Progression Free Survival (PFS)
时间窗: up to month 37
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
未报告次要终点
研究者
研究点 (29)
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