Actively Recruiting
Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
Led by University of Milano Bicocca · Updated on 2025-07-25
25
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed histologically confirmed glioblastoma (WHO grade IV, IDH wild type) undergoing surgical resection
- MGMT gene promoter methylation status assessed post-surgery (hypomethylation or hypermethylation)
- Adults aged 18 years or older, any sex
- Patients undergoing the Stupp protocol, including those over 70 years following the hypofractionated protocol and three weeks of chemotherapy
- Karnofsky Performance Status (KPS) above 60 assessed after surgery
- Life expectancy of at least 6 months based on tumor size and location
- Provided freely given written informed consent and able to communicate and comply with study procedures
- Women of childbearing potential must test negative for pregnancy and agree to use effective contraception during treatment and for four weeks after the last dose
- Male participants with female partners of childbearing age must use condoms during treatment and until systemic exposure ends
You will not qualify if you...
- Multicentric glioblastomas
- Diagnosis of diabetes or diabetes-related conditions
- Presence of other active cancers
- Known hypersensitivity or intolerance to metformin or its ingredients
- Impaired kidney function with creatinine clearance below 60 mL/min
- Liver failure or abnormal liver enzyme levels at recruitment
- Use of metformin, insulin, or other biguanides for any reason
- Pregnancy or breastfeeding
- Serious pre-existing medical conditions that would prevent safe participation in the study as determined by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, Italy
Actively Recruiting
Research Team
M
Manuela Caroli, Dott.ssa
CONTACT
R
Rosa Maria Moresco, Dott.ssa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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