SARC029: Phase II Pilot Study of Trametinib in Combination With Pazopanib in Patients With Metastatic or Local-regionally Recurrent GIST (Gastrointestinal Stromal Tumor) Refractory or Intolerant to at Least Imatinib and Sunitinib
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
This study evaluates the combination of trametinib and pazopanib in patients with advanced gastrointestinal stromal tumors (GIST).
详细描述
Trametinib and pazopanib are independently approved for other cancers. Both drugs work to inhibit tumor development in different ways. Combining these drugs may lead to improved disease control. The purpose of this study is to evaluate the effect of the combination of both drugs on advanced 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Trametinib with Pazopanib
Participants will take pazopanib (800mg) and trametinib (2mg) by mouth daily for a 28 day cycle.
干预措施: Pazopanib (Drug)
Trametinib with Pazopanib
Participants will take pazopanib (800mg) and trametinib (2mg) by mouth daily for a 28 day cycle.
干预措施: Trametinib (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: 16 weeks
Disease Control Rate (DCR) is the percentage of patients who have achieved complete response, partial response and stable disease to study treatment
次要结局
- Overall Survival (OS)(up to 10 years)
- Progression Free Survival (PFS)(Up to 12 months)
- Number and type of adverse events(up to 2 years)