Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms

Use of Metformin in Patients With Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms

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).

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.

Key Inclusion Criteria (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

Key Exclusion Criteria (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