| Trial ID # | NCT02101788 |
| Phase | III |
| Drug Class | Signaling Pathway Inhibitors: RAS-RAF-MEK-ERK/MEK |
| Drug Name | Trametinib |
| Alternate Drug Names | Mekinist, MEK Inhibitor GSK1120212, JTP-74057, GSK1120212, TMT212 |
| Drugs in Trial | Letrozole, Liposomal doxorubicin, Paclitaxel, Tamoxifen, Topotecan, Trametinib |
| Eligible Participant | Recurrent low grade serous ovarian cancer |
| Patients Enrolled | 260; median 3 prior therapies |
| Therapy Setting | Recurrence |
| Study Design | Double Blind, Randomized |
| Endpoints | ORR, DoR, PFS, OS, evaluated per RECIST |
| Efficacy | Tra vs Standard of Care Treatment of Physician's Choice (TPC) (Let, Pac, PLD, Tam or Top): ORR: 26.2 vs 6.2% (p<0.0001) |
| Clinically Significant Adverse Events | Tra vs TPC: |
| Conclusion | In low grade serous ovarian cancer trametinib therapy was associated with significantly improved ORR and PFS compared to standard of care |
| Reference | Gershenson GM et al. A randomized phase II/III study to assess the efficacy of trametinib in patients with recurrent or progressive low-grade serous ovarian or peritoneal cancer. ESMO (2019) Abstr LBA61 |