Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Ann Karmanos Cancer Institute
About this trial
The goal of this clinical trial is to evaluate the safety of Metformin alone and in combination with chemotherapy or immunotherapy in patients with solid tumor cancers. The main questions it aims to answer are:
* what are the toxicities of metformin at multiple dose levels * what is the maximum tolerated dose of Metformin in combination with chemotherapy or immunotherapy
Participants enrolled will be treated with standard of care chemotherapy and/or immunotherapy in accordance to their disease/stage. In addition, participants will take Metformin alone for 14 days in between the first cycle of chemotherapy and the second cycle of chemotherapy to determine tolerability to the Metformin. Participants will then take Metformin daily in combination with the standard of care chemotherapy and/or Immunotherapy from cycle 2 onwards.
Eligibility criteria
Qualifiers
Have histologically confirmed advanced solid tumor and are considered a suitable candidate for chemotherapy and/or immunotherapy or both
Are a male or female participant aged ≥ 18 years
Have provided a signed, written informed consent form
Have measurable disease per RECIST v1.1
Disqualifiers
Patients who have or are any of the following exclusion criteria are not eligible for participation in the study.
Patients with uncontrolled diabetes
Patients who have received metformin must be at least five half-lives beyond such treatment (four weeks) and must not be taking metformin at the time of enrollment.
Patients with a known hypersensitivity to metformin, its excipients, its analogs, or any of its components
Trial design
Treatments tested in this trial
- Metformin
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov