Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms

NCT07693452 — Phase 2, Recruiting, 15 participants, University of California, Irvine

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

Registry	NCT07693452
Status	Recruiting
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	15 (Estimated)
Sponsor	University of California, Irvine (Other)
Conditions	Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei
Interventions	Metformin (Drug)
Dates	start 2026-06-18, primary completion 2028-02-01 (estimated), completion 2029-07-01 (estimated), first posted 2026-07-09, last updated 2026-07-13
Locations	1 site in United States

-Summary

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).

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+Detailed 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 pseudomyxoma peritonei (PMP) secondary to AMNs.

+Arms and interventions

Arm	Type	Interventions	Description
Metformin Treatment	Experimental	Drug: Metformin	850mg PO daily

Metformin (Drug): Given PO

+Outcome measures

Primary outcomes

Proportion of Participants who have completed at least (≥) 80% of planned metformin doses by 6 months [6 months]: Examine the feasibility of metformin therapy in patients with pseudomyxoma peritonei (PMP) secondary to appendiceal mucinous neoplasms (AMNs)

Secondary outcomes

Progression Free Survival (PFS) [6, 12 and 18 months]: Examine efficacy of metformin therapy in patients with PMP secondary to AMNs as assessed by progression free survival (PFS). Progression free survival will be defined by relative best tumor size change from baseline ranging from -100% to 100%, with radiographic findings assessed via modified peritoneal RECIST criteria at 6/12/18 months.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Chao Family Comprehensive Cancer Center, University of California, Irvine	Orange, California	United States	Recruiting

+Investigators

Oliver Eng, MD, Principal investigator, Chao Family Comprehensive Cancer Center