| Trial ID # | NCT01579812 |
| Phase | II |
| Drug Class | Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR |
| Drug Name | Metformin |
| Alternate Drug Names | Fortamet, Glucophage, Glumetza, Riomet |
| Drugs in Trial | Carboplatin, Metformin, Paclitaxel |
| Eligible Participant | Newly diagnosed stage IIC-IV ovarian cancer |
| Patients Enrolled | 38 (61% neo-adjuvant chemo+metformin and IDS, 39% neo-adjuvant metformin and PDS) |
| Therapy Setting | First-line |
| Study Design | Open-Label, Non-randomized |
| Endpoints | PFS, OS, evaluated per RECIST |
| Efficacy | PFS: 18.0 months |
| Clinically Significant Adverse Events | Serious AE: none |
| Conclusion | Metformin treatment before surgery and added to first-line chemotherapy is well tolerated and is associated with a better than expected OS, particularly in patients with stage II-III disease |
| Reference | Brown JR et al. Phase II clinical trial of metformin as a cancer stem cell-targeting agent in ovarian cancer. JCI insights (2020) 5(11):e133247 |