[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07693452":3,"trial-entities:NCT07693452":94,"trial-summary:NCT07693452":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":63,"locations":66,"central_contacts":82,"overall_officials":88,"references":92,"see_also_links":93},"NCT07693452","STUDY00000747","Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms","Use of Metformin in Patients With Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms","RECRUITING","2029-07","2026-07","2026-07-13","2026-06-18","University of California, Irvine","OTHER",true,"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).","This is a single-arm, prospective pilot\u002Ffeasibility 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.",[19,20],"Appendiceal Mucinous Neoplasm","Pseudomyxoma Peritonei",[19,20,22,23,24,25],"Pseudomyxoma Peritoneal","PMP","AMNs","Metformin","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},15,"ESTIMATED",[34],{"type":35,"name":25,"description":36,"armGroupLabels":37},"DRUG","Given PO",[38],"Metformin Treatment",[40],{"measure":41,"description":42,"timeFrame":43},"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",[45],{"measure":46,"description":47,"timeFrame":48},"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\u002F12\u002F18 months.","6, 12 and 18 months","ALL","18 Years",null,false,{"inclusion":54,"exclusion":58,"raw_text":62},[55,56,57],"Patients with clinical diagnosis of pseudomyxoma peritonei (PMP) secondary to presumed appendiceal mucinous neoplasms (AMNs) with recurrent\u002Frefractory disease s\u002Fp cytoreductive surgery(CRS)\u002Fhyperthermic intraperitoneal chemotherapy (HIPEC), unresectable disease, or without planned CRS\u002FHIPEC","Age ≥18 years","ECOG performance status ≤2",[59,60,61],"Patients with a clinical diagnosis of PMP secondary to presumed AMNs with resectable disease who are planned to undergo CRS\u002FHIPEC","Patients currently taking metformin for another medical indication","Patients with a prior adverse event to administration of metformin","Key Inclusion Criteria (complete details available in protocol):\n\n* Patients with clinical diagnosis of pseudomyxoma peritonei (PMP) secondary to presumed appendiceal mucinous neoplasms (AMNs) with recurrent\u002Frefractory disease s\u002Fp cytoreductive surgery(CRS)\u002Fhyperthermic intraperitoneal chemotherapy (HIPEC), unresectable disease, or without planned CRS\u002FHIPEC\n* Age ≥18 years\n* ECOG performance status ≤2\n\nKey Exclusion Criteria (complete details available in protocol):\n\n* Patients with a clinical diagnosis of PMP secondary to presumed AMNs with resectable disease who are planned to undergo CRS\u002FHIPEC\n* Patients currently taking metformin for another medical indication\n* Patients with a prior adverse event to administration of metformin",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":79},"Chao Family Comprehensive Cancer Center, University of California, Irvine","Orange","California","92868","United States",[74],{"name":75,"role":76,"phone":77,"email":78},"Oliver Eng, MD","CONTACT","877-827-8839","ucstudy@uci.edu",{"lat":80,"lon":81},33.78779,-117.85311,[83,86],{"name":84,"role":76,"phone":85,"email":78},"Chao Family Comprehensive Cancer Center University of California, Irvine","1-877-827-8839",{"name":87,"role":76},"University of California Irvine Medical",[89],{"name":75,"affiliation":90,"role":91},"Chao Family Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96,20],"Appendiceal mucinous neoplasm",[],{"nct_id":4,"found":15,"summary":99,"prompt_version":109},{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is a single-arm, open-label pilot study, meaning all 15 participants will receive metformin. It's designed to see if metformin treatment is feasible.","completed","Metformin for Pseudomyxoma Peritonei","This study is testing if metformin, a common diabetes medication, can be a practical treatment for people with pseudomyxoma peritonei (PMP). PMP is a rare cancer that often starts in the appendix (appendiceal mucinous neoplasms or AMNs). You might be able to join if you have PMP from AMNs that has come back, can't be removed by surgery, or if surgery isn't planned. The main goal is to see if participants can take at least 80% of their planned metformin doses for 6 months. This is a pilot study, meaning it's a small first step to see if this treatment is feasible. The study is currently unclear about its recruitment status and plans to enroll 15 participants.","The primary goal is measured at 6 months, but treatment can continue for up to 18 months.",117,"You would take metformin by mouth for up to 18 months, or until you can no longer tolerate the treatment.","Not stated in the trial record.",[25],"v2"]