Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Multicenter GBMs;
Patients diagnosed with diabetes or diabetes-related conditions;
other active malignancies;
hypersensitivity, intolerance to metformin or excipients;
Trial design
Treatments tested in this trial
- Metformin
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov