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NCT Number: NCT07693452

Metformin in 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).

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Key information

Conditions

Appendiceal Mucinous Neoplasm Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Glandular and Epithelial Pseudomyxoma Peritonei

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Oliver Eng, MD

CONTACT

[email protected]

877-827-8839

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Given PO

Primary outcomes

  1. Proportion of Participants who have completed at least (≥) 80% of planned metformin doses by 6 months

    Time frame: 6 months

    Examine the feasibility of metformin therapy in patients with pseudomyxoma peritonei (PMP) secondary to appendiceal mucinous neoplasms (AMNs)

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 9, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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