NCT07693452

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
36mo left

Started Jun 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jul 2029

Study Start

First participant enrolled

June 18, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 3, 2026

Last Update Submit

July 9, 2026

Conditions

Appendiceal Mucinous NeoplasmPseudomyxoma Peritonei

Keywords

Appendiceal Mucinous NeoplasmPseudomyxoma PeritoneiPseudomyxoma PeritonealPMPAMNsMetformin

Outcome Measures

Primary Outcomes (1)

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

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

    6 months

Secondary Outcomes (1)

  • Progression Free Survival (PFS)

    6, 12 and 18 months

Study Arms (1)

Metformin Treatment

EXPERIMENTAL

850mg PO daily

Drug: Metformin

Interventions

MetforminDRUG

Given PO

Metformin Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Pseudomyxoma Peritonei

Interventions

Metformin

Condition Hierarchy (Ancestors)

Adenocarcinoma, MucinousAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Oliver Eng, MD

    Chao Family Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

June 18, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations

US(1)