Metformin in Pseudomyxoma Peritonei Secondary to Appendic... | NCT07693452

Studies
Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms

NCT07693452

Sponsor

University of California, Irvine

Status

Recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

15Estimated

Phase

Phase 2

Conditions

Appendiceal Mucinous Neoplasm
Pseudomyxoma Peritonei

Interventions

Metformin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UCI 25-149	Other Identifier	UCI CFCCC

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2026Actual

Primary Completion Date

Feb 2028Estimated

Completion Date

Jul 2029Estimated

First Submitted Date

Jul 3, 2026

First Submission Date that Met QC Criteria

Jul 3, 2026

First Posted Date

Jul 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 9, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oliver Eng, Associate Professor, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

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 PMP secondary to AMNs.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin Treatment	Experimental	850mg PO daily	Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	Given PO	Metformin Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 PMP secondary to AMNs	6 months

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	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.	6, 12 and 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chao Family Comprehensive Cancer Center University of California, Irvine	Contact	1-877-827-8839		ucstudy@uci.edu
University of California Irvine Medical	Contact

Overall Officials

Name	Affiliation	Role
Oliver Eng, MD	Chao Family Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chao Family Comprehensive Cancer Center, University of California, Irvine	Recruiting	Orange	California	92868	United States

Condition Browse Module

MeSH Terms

ID	Term
D011553	Pseudomyxoma Peritonei

Ancestor Terms

ID	Term
D002288	Adenocarcinoma, Mucinous
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided