Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin.
- Who it may be relevant to
- Registry conditions: Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Metformin in Patients With Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
Overview
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.
Interventions
- Drug Metformin
Given PO
Primary outcome measures
- Proportion of Participants who have completed at least (≥) 80% of planned metformin doses by 6 months [Time frame: 6 months]
Secondary outcome measures (1)
- Progression Free Survival (PFS) [Time frame: 6, 12 and 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange
Identifiers
NCT: NCT07693452 · STUDY00000747 · UCI 25-149