An Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Percent of Patients Achieving Stable Disease (SD)
研究概览
简要总结
This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.
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 and therefore not amenable to surgery or combined modality with curative intent.
- •Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included.)
- •At least one measurable site of disease on CT/MRI as defined by RECIST criteria.
排除标准
- •Prior treatment with nilotinib.
- •Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit
- •Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
- •Impaired cardiac function at visit 1
- •Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Nilotinib
nilotinib 400 mg twice daily (bid).
干预措施: Nilotinib (Drug)
结局指标
主要结局
Percent of Patients Achieving Stable Disease (SD)
时间窗: During the first 4 months
Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.
Percent of Patients Achieving Partial Response (PR)
时间窗: during the first 4 months
The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Percent of Patients Achieving Complete Response (CR)
时间窗: during the first 4 months
Complete response (CR) is the Disappearance of all target lesions.
次要结局
- Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population(24 weeks and 52 weeks)
- Time to Overall Response (CR or PR): Per Protocol Population(24 weeks and 52 weeks)
- Time to Tumor Progression(during the first 4 months)
- Duration of Overall Response(during 12 months)
- Overall Survival, Number of Events Related to Progression of the Disease(during 12 months)
- Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment.(during 12 months)