Metformin Clinical Trial for Solid Malignancies Underway

Strategic Insights -

Researchers at the Barbara Ann Karmanos Cancer Institute are conducting a Phase 1 clinical trial to study the safety of metformin when combined with chemotherapy and/or immunotherapy in patients with solid tumor cancers. The trial aims to evaluate the toxicities of metformin at multiple dose levels and determine the maximum tolerated dose when combined with standard treatments. Participants will be treated with standard care chemotherapy and/or immunotherapy, and in addition, will take metformin alone for 14 days between the first and second cycles of chemotherapy to assess tolerability.

Key Takeaways:

  • The clinical trial, led by Wasif Saif, M.D., is designed to evaluate the safety of metformin in combination with chemotherapy and/or immunotherapy in patients with solid tumor cancers.
  • The trial will enroll a sample of 60 participants from the USA and will assess the toxicities of metformin at multiple dose levels.
  • Participants will be treated with standard of care chemotherapy and/or immunotherapy, and will also take metformin alone for 14 days in between the first and second cycles of chemotherapy to determine tolerability.
  • The trial aims to determine the maximum tolerated dose of metformin in combination with chemotherapy or immunotherapy.
  • Participants will take metformin daily in combination with standard of care chemotherapy and/or immunotherapy from cycle 2 onwards.
  • The trial is not yet open for recruiting, and interested participants should be in contact with the study team for further information.

Statistics:

  • The trial will enroll a sample of 60 participants from the USA.
  • The trial aims to evaluate the toxicities of metformin at multiple dose levels.
  • Participants will be treated with standard of care chemotherapy and/or immunotherapy.
  • The trial will assess the maximum tolerated dose of metformin in combination with chemotherapy or immunotherapy.
  • The trial is listed on ClincialTrials.gov with the identifier NCT07098299.
  • The trial is being conducted by the Barbara Ann Karmanos Cancer Institute.

Sources:

  • ClinicalTrials.gov
  • NCT07098299