NCT05929495
Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
Recruiting · Phase 2 · University of Milano Bicocca · registry updated 2025-07-25
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies. This is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months. The clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.
Inclusion
- Patients with newly diagnosed histologically confirmed GBM (WHO grade IV, IDH wild type) undergoing surgical resection;
- hypomethylation or hypermethylation of MGMT assessed post-surgery;
- adult patients (≥18 years), both sexes;
- Patients undergoing Stupp protocol including patients aged \> 70 years performing the hypofractionated protocol and three weeks of chemotherapy;
- Karnofsky Performance Status (KPS)\> 60 assessed post-surgery;
- life expectancy at least 6 months defined by size and location of lesion tumor;
Exclusion
- Multicenter GBMs;
- Patients diagnosed with diabetes or diabetes-related conditions;
- other active malignancies;
- hypersensitivity, intolerance to metformin or excipients;
- Impaired renal function with creatinine clearance \< 60 mL/min assessed at recruitment, liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin, and other contraindications to metformin use;
- taking metformin, insulin or other biguanides, regardless of the reason;