A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 5
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.
详细描述
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Masitinib
Participants receive masitinib (12 mg/kg/day), given orally twice daily.
干预措施: Masitinib (Drug)
Sunitinib
Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
干预措施: Sunitinib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From day of randomization to death, assessed for a maximum of 60 months
Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.
次要结局
- Survival rate(Every 12 weeks until study completion, assessed for a maximum of 60 months)
- Progression Free Survival (PFS)(From day of randomization to disease progression or death, assessed for a maximum of 60 months)