Overview
This is a pilot, open-label clinical trial determining the feasibility of metformin therapy in subjects with pseudomyxoma peritoneal (PMP) secondary to appendiceal mucinous neoplasms (AMNs).
Description
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 PMP secondary to AMNs.
Eligibility
Key Inclusion Criteria (complete details available in protocol):
- Patients with clinical diagnosis of PMP secondary to presumed AMNs with recurrent/refractory disease s/p CRS/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
