A Phase 1 interventional study of Metformin in Advanced Solid Tumor, sponsored by Barbara Ann Karmanos Cancer Institute. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 1, Interventional, and Treatment
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:
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.
Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Have adequate hematologic, renal, liver, and coagulation function as defined by the following:
Exclusion Criteria:
Patients with clinically significant intercurrent disease including, but not limited to:
Metformin will be administered in combination with any standard chemotherapy/immunotherapy. Metformin 1000mg-3000mg day in dose escalation
Drug: Metformin
Metformin will be given for 14 days alone as a run in and then added to any standard of care chemotherapy or immunotherapy for solid tumors.
Incidence of Dose Limiting Toxicities (DLTs)-Metformin only stage
Adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).
Time frame: From the start of Metformin run in to the end of Metformin run in. Up to 14 days
Incidence of Dose Limiting Toxicities (DLTs)-Chemotherapy or Immunotherapy (IO) plus Metformin Stage
Adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).
Time frame: From start of Chemotherapy or IO plus Metformin until 30 days after the end of treatment
Determine the maximum tolerated dose (MTD) of metformin in combination with chemotherapy/IO
The MTD will be defined as the dose level below the dose level at which two or more patients in the same cohort experience a DLT. If none or only one patient experiences a DLT at level 5, then dose level 5 will be defined as the MTD.
Time frame: Up to 4 months after treatment initiation
Assessment of overall response rate (ORR)
Tumor response will be determined according to RECIST v1.1. Treatment responses will be summarized by count and percentage, and their rates will be computed along with their associated two-sided 95% confidence intervals (CIs).
Time frame: Up to 4 months after treatment initiation
Assessment of Duration of Response (DOR)
Tumor response will be determined according to RECIST v1.1. The DOR is measured from the time measurement criteria are met for complete response (CR) or a partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Treatment responses will be summarized by count and percentage, and their rates will be computed along with their associated two-sided 95% confidence intervals (CIs). The distributions of time-to-event data, such as DOR and PFS will be graphically summarized using Kaplan-Meier (KM) curves, and their median and 95% CIs will be estimated using KM estimates.
Time frame: Up to 4 months after treatment initiation
Assessment of Progression free survival (PFS)
Tumor response will be determined according to RECIST v1.1. Progression-free survival (PFS) is defined as the time duration from treatment start to progression time or death, whichever occurs first. Treatment responses will be summarized by count and percentage, and their rates will be computed along with their associated two-sided 95% confidence intervals (CIs). The distributions of time-to-event data, such as DOR and PFS will be graphically summarized using Kaplan-Meier (KM) curves, and their median and 95% CIs will be estimated using KM estimates.
Time frame: Up to 4 months after treatment initiation
Evaluate extracellular nicotinamide phosphoribosyltransferase (eNAMPT) as a surrogate marker for nicotinamide adenine dinucleotide (NAD) signaling inhibition
Serum NAD+ and eNAMPT will be measured at baseline and every 8 weeks after the start of metformin. Enzyme linked immunosorbent assays (ELISAs) will be used to determine levels. Summary statistics (numerical and/or graphical) for changes of NAD+ and eNAMPT levels between baseline and after treatment will be evaluated, along with their summaries at the baseline and at after treatment. Correlations between NAD+ and eNAMPT to the ORR, DOR, and PFS will be calculated from patients who have a partial (at least a 30%) complete response to treatment.
Time frame: Up to 4 months after treatment initiation
Assess metabolic parameters
Glycated hemoglobin, glucose, insulin, Insulin like growth factor-1, and C-peptide levels will be measured at baseline and every 8 weeks after the start of metformin. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated at the same timepoints. Summary statistics (numerical and/or graphical) of the metabolic parameters will be evaluated at baseline and every 8 weeks. Comparing the pretreatment biomarker levels with the post treatment levels to determine the effect of the drug using Wilcoxon signed rank test. The differences between the responding and non-responding groups using Wilcoxon-Mann-Whitney test for statistical significance will also be compared. The correlation of the metabolic parameters with tumor markers and efficacy (ORR, DOR, and PFS) will be assessed using Pearson correlation and scatter plots.
Time frame: Up to 4 months after treatment initiation
Perform metabolomics analysis
Blood will be drawn at baseline and every 8 weeks after the start of treatment. Using Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) and MetaboAnalyst, a panel of over 200 polar metabolites will be investigated and their correlation with metformin responsiveness and PFS will be evaluated.
Time frame: Up to 4 months after treatment initiation
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Barbara Ann Karmanos Cancer Institute