A Phase II Evaluation of Metformin, Targeting Cancer Stem Cells for the Prevention of Relapse in Patients With Stage IIC/III/IV Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

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 OS: 57.9 months
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 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 https://pubmed.ncbi.nlm.nih.gov/32369446/