Tests metformin added to standard treatment for high-grade brain tumors
Tests metformin with temozolomide in adults with IDH-wildtype glioblastoma, a brain cancer.
Plain-language title generated from the registry record
Registry title: Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
Key facts
- Where
- Milan, ItalySee the site
- Phase
- Phase 2
Where in Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MilanoMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Milano Bicocca
- Trial code
- NCT05929495
- Record updated
- 25 July 2025
- Original description
About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies.Read full original descriptionShow less
Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
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; freely given written informed consent prior to any activity related to the study. Patients must be able to communicate with the investigator and comply with the study procedures; Women of childbearing age must test negative for pregnancy at enrollment and, if they have sexual intercourse, they must agree to use specific contraceptive methods. Female subjects of childbearing age, i.e., fertile, after menarche and until post-menopause unless they are permanently infertile, who are sexually active, must apply a highly effective method of birth control with a low failure rate (i.e., less than 1 percent per year), such as combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral intravaginal, or transdermal), progestin-only hormonal contraception associated with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone delivery system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence, throughout the treatment period and for four weeks after the last dose of the study treatment. Hormonal methods other than levonorgestrel-containing devices or medroxyprogesterone injections should be supplemented with the use of a male condom. Women of nonfertile age may be included if surgically sterile or postmenopausal for at least 2 years. The investigator is responsible for determining whether the patient has adopted an appropriate method of contraception for participation in the study; Male subjects with female partners of childbearing age must use condoms during treatment and until the end of relevant systemic exposure.
Exclusion: Patients diagnosed with diabetes or diabetes-related conditions; other active malignancies; hypersensitivity, intolerance to metformin or excipients; patient has serious pre-existing medical conditions that, in the opinion of the investigator, would preclude participation in this study; 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; Multicenter GBMs; taking metformin, insulin or other biguanides, regardless of the reason; pregnancy or lactation.