A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 361
- 试验地点
- 1
- 主要终点
- Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase
研究概览
简要总结
A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.
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
- Double (Participant, Investigator)
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-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
- •Failed Gleevec treatment or intolerant to Gleevec therapy
排除标准
- •Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec
研究组 & 干预措施
B
干预措施: Placebo (Drug)
A
干预措施: SU011248 (Drug)
结局指标
主要结局
Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase
时间窗: Day 28 of each 6-week cycle : duration of double-blind treatment phase
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study
时间窗: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
次要结局
- Time to Tumor Response (TTR)(Day 28 of each cycle : duration of double-blind treatment phase)
- Duration of Performance Status Maintenance(Day 28 of each cycle : duration of double-blind treatment phase)
- Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)(Day 1 & 28 of each cycle : duration of double-blind treatment phase)
- Overall Survival Status of Subjects(clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug)
- Overall Survival(clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug)
- Overall Survival Based on the Rank Preserving Structural Failure Time Method(clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug)
- Best Overall Tumor Response During Double-blind Treatment Phase(Day 28 of each cycle : duration of double-blind treatment phase)
- Confirmed Objective Response (CR or PR) in Subjects(Day 28 of each cycle : duration of double-blind treatment phase)
- Progression Free Survival (PFS)(Day 28 of each cycle : duration of double-blind treatment phase)
- Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)(Day 1 & 28 of each cycle : duration of double-blind treatment phase)
- Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)(Day 1 & 28 of each cycle : duration of double-blind treatment phase)
- Change From Baseline in EQ-5D Health State Profile Index(Day 1 & 28 of each cycle : duration of double-blind treatment phase)