A Phase IIIB, Randomized, Active Controlled Open-Label Study Of Sunitinib (Sutent) 37.5 Mg Daily Vs Imatinib Mesylate 800 Mg Daily In The Treatment Of Patients With Gastrointestinal Stromal Tumors (GIST) Who Have Had Progressive Disease While On 400 Mg Daily Of Imatinib
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.
详细描述
The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.
排除标准
- •Current treatment with any chemotherapy other than imatinib.
- •Current treatment with any dose of imatinib other than 400 mg
研究组 & 干预措施
B
干预措施: imatinib mesylate (Drug)
A
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline, Week 5, and every 8 weeks until Year 2
Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.
次要结局
- Overall Survival (OS)(Baseline up to 2 years)
- Time to Pain Relief Response (TTPR)(Day 28 of Cycle 1 up to 26)
- Time to Treatment Failure (TTF)(Day 28 of Cycle 1 up to 26)
- Number of Participants With Objective Response of Complete Response or Partial Response(Day 28 of Cycle 1 up to 26)
- Time to Tumor Response (TTR)(Day 28 of Cycle 1 up to 26)
- Duration of Response (DR)(Day 28 of Cycle 1 up to 26)
- Time to Pain Progression (TTPP)(Day 28 of Cycle 1 up to 26)
- Number of Participants With Pain Relief Response(Day 28 of Cycle 1 up to 26)
- Number of Participants With Pain Progression(Day 28 of Cycle 1 up to 26)
- Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm(Days 1 and 28 of each cycle)
- Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm(Days 1 and 28 of each cycle)
- Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm(Days 1 and 28 of each cycle)
- Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm(Days 1 and 28 of each cycle)