Table 1.
Clinical trials with metformin and other chemotherapeutic agents.
| Cancer type | Phase | Primary outcome | Dosing regimen | Combination | Enrollment number | Clinical trial ref | Completion time |
|---|---|---|---|---|---|---|---|
| Breast cancer [43] | 0 | Changes in Ki67 | Metformin+atorvastatin | Metformin, atorvastatin | 40 | NCT01980823 | 2021 |
| Breast cancer [44] | II | Effects of metformin on AMPK/m/TOR pathway | Metformin 1500 mg daily for 2 weeks before surgery | Metformin monotherapy | 35 | NCT00930579 | 2014 |
| Breast, lung, liver, kidney [45] | I | Effect of metformin+sirolimus on p70S6K | Sirolimus 3 mg daily for 1-7 days. Metformin 500 mg once daily for 8-21 days | Metformin, sirolimus | 64 | NCT02145559 | 2018 |
| Colorectal [46] | II | Disease control rate | FOLFOX+metformin/FOLFIRI+metformin | Metformin, FOLFOX6 | 48 | NCT01926769 | 2014 |
| Prostate [47] | I | DLT assessed at 28days | Enzalutamide PO QD and metformin PO BID | Metformin, enzalutamide | 24 | NCT02339168 | 2021 |
| Pancreas [48] | II | PFS at 12 months | Everolimus+octreotide LAR+metformin | Metformin everolimus, octreotide LAR | 43 | NCT02294006 | 2017 |
| Chronic lymphocytic leukemia [49] | II | Time to treatment failure (assessed 3 months) | Metformin 500 mg PO QD, increased to 500 mg BID after 1week and to 1000 mg BID at week 3 | Metformin monotherapy | 53 | NCT01750567 | 2020 |
| Breast cancer, early stage [50] | III | DFS for a 10-year duration | Arm I: oral metformin HCl QD for 1-4 weeks, then BID afterwards. Treatment for 5 years Arm II: placebo given the same way as metformin in Arm I. |
3649 | NCT01101438 | 2022 |
PFS: progression-free survival; RFS: relapse-free survival; DLT: dose-limiting toxicity; FOLFOX: folinic acid, fluorouracil, oxaliplatin; QD: once daily; BID: two times daily; FOLFIRI: irinotecan, folinic acid, fluorouracil.