Phase 2 Brain Cancer Trial, Recruiting NCT05929495 Sponsor: University of Milano Bicocca Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT05929495
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been newly diagnosed with a specific type of brain tumour called glioblastoma (GBM, WHO grade IV, IDH wild type) and have had surgery to remove or reduce the tumour
  • People who have had a specific gene marker on the tumour (called MGMT methylation status) tested after surgery, regardless of the result
  • Adults aged 18 years or older, of any sex
  • People who are receiving the standard treatment plan for this type of brain tumour (known as the Stupp protocol), including older patients over 70 who are on a shorter radiation schedule and three weeks of chemotherapy
  • People whose general physical functioning, as measured by a specific scoring system (Karnofsky Performance Status), is above 60 after surgery — meaning they are able to care for themselves and carry out some normal activities (confirm with trial site)
  • People whose tumour size and location suggest a life expectancy of at least 6 months
  • People who are able to communicate with the research team and are willing and able to follow all study procedures, and who have given written consent before any study activities begin
  • Women who could become pregnant must have a negative pregnancy test at the start of the trial, and must agree to use a highly effective form of contraception throughout treatment and for four weeks after the last dose — the trial site can advise on which methods are accepted
  • Men with female partners who could become pregnant must use condoms during treatment and until the end of relevant exposure from the study treatment

Who may not be able to join:

  • People whose glioblastoma has spread to or appears in multiple separate areas of the brain (multicentric GBM)
  • People who have been diagnosed with diabetes or any diabetes-related condition
  • People who currently have another active cancer
  • People who have a known allergy or intolerance to metformin or any of its ingredients
  • People with reduced kidney function (creatinine clearance below 60 mL/min), liver failure, or other medical reasons that would prevent safe use of metformin, as assessed at the time of recruitment
  • People who are already taking metformin, insulin, or other medications in the same drug family (biguanides), for any reason
  • People who are pregnant or currently breastfeeding
  • People who have serious pre-existing health conditions that the trial doctor believes would make participation unsafe or unsuitable

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 0255035502

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Milano Bicocca
Registry
ClinicalTrials.gov
Start date
12 February 2024
Est. completion
1 January 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Value of PFS at 6 months after the start of treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov