Use of Metformin in Patients With Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of Participants who have completed at least (≥) 80% of planned metformin doses by 6 months
研究概览
简要总结
This is a pilot, open-label clinical trial determining the feasibility of metformin therapy in subjects with pseudomyxoma peritonei (PMP) secondary to appendiceal mucinous neoplasms (AMNs).
详细描述
This is a single-arm, prospective pilot/feasibility study. Treatment will continue for the duration of the study (18 months) or intolerance to treatment. The primary endpoint will be feasibility of metformin therapy in patients with pseudomyxoma peritonei (PMP) secondary to AMNs.
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
- •(complete details available in protocol):
- •Patients with clinical diagnosis of pseudomyxoma peritonei (PMP) secondary to presumed appendiceal mucinous neoplasms (AMNs) with recurrent/refractory disease s/p cytoreductive surgery(CRS)/hyperthermic intraperitoneal chemotherapy (HIPEC), unresectable disease, or without planned CRS/HIPEC
- •Age ≥18 years
- •ECOG performance status ≤2
排除标准
- •(complete details available in protocol):
- •Patients with a clinical diagnosis of PMP secondary to presumed AMNs with resectable disease who are planned to undergo CRS/HIPEC
- •Patients currently taking metformin for another medical indication
- •Patients with a prior adverse event to administration of metformin
研究组 & 干预措施
Metformin Treatment
850mg PO daily
干预措施: Metformin (Drug)
结局指标
主要结局
Proportion of Participants who have completed at least (≥) 80% of planned metformin doses by 6 months
时间窗: 6 months
Examine the feasibility of metformin therapy in patients with pseudomyxoma peritonei (PMP) secondary to appendiceal mucinous neoplasms (AMNs)
次要结局
- Progression Free Survival (PFS)(6, 12 and 18 months)
研究者
Oliver Eng
Associate Professor
University of California, Irvine