Appendiceal Mucinous NeoplasmPhase 2NCT07693452
Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
A Phase 2 study testing Metformin in people with Appendiceal Mucinous Neoplasm and Pseudomyxoma Peritonei, run by University of California, Irvine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Oliver Eng, MD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Use of Metformin in Patients With 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).
Read the 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.
- Being tested
- Metformin
- Keywords
- Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei, Pseudomyxoma Peritoneal, PMP, AMNs, Metformin
- Medical subject headings
- Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Metformin Treatment | Experimental | 850mg PO daily Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start18 Jun 2026
- Primary completionFeb 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendiceal Mucinous NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Eng, University of California, Irvine
- Investigators
- Oliver Eng, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693452
- Sponsor's protocol ID
- STUDY00000747
- Other IDs
- UCI 25-149
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Metformin in Patients With Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
- ClinicalTrials.gov ID
- NCT07693452
- Acronym / sponsor ID
- STUDY00000747
- Keywords
- Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei, Pseudomyxoma Peritoneal, PMP, AMNs, Metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin Treatment | Experimental | Drug: Metformin850mg PO daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminGiven PO | Drug | Metformin Treatment |
Primary outcome
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)
1 secondary outcome
Progression Free Survival (PFS)
Time frame: 6, 12 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Related trials for Appendiceal Mucinous Neoplasm
RecruitingPhase 1
TLR9 Immunotherapy for Peritoneal Carcinomatosis
Malignant Ascites, Colorectal Adenocarcinoma
RecruitingPhase 2
Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B)
Esophageal Carcinoma, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)
Phase II, Ivonescimab
RecruitingObservational study
The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
Appendix Cancer, Pseudomyxoma Peritonei
RecruitingPhase 1/2
A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
Metastatic Appendiceal Adenocarcinoma, Intraperitoneal Paclitaxel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Oliver Eng, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Appendiceal Mucinous Neoplasm and Pseudomyxoma Peritonei, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants who have completed at least (≥) 80% of planned metformin doses by 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.