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


Study Design

Open-Label, Non-randomized


PFS, OS, evaluated per RECIST


PFS: 18.0 months
OS: 57.9 months

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: none


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


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

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