Trial ID # | NCT03673124 |
Phase | II |
Drug Class | Cell Cycle Inhibitors: CDK4/6 |
Drug Name | Ribociclib |
Alternate Drug Names | Kisqali, CDK4/6 Inhibitor LEE011, LEE011 |
Drugs in Trial | Letrozole, Ribociclib |
Eligible Participant | Recurrent low grade serous ovarian cancer |
Patients Enrolled | 48, median 1 prior therapy (0-3) |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, DCR, DoR, PFS, evaluated per RECIST |
Efficacy | ORR: 23% (11PR, n=42) |
Clinically Significant Adverse Events | Serious AE: |
Conclusion | The combination of letrozole plus ribociclib demonstrates promising activity in women with recurrent LGSOC |
Reference | Slomovitz B et al. GOG 3026 A Phase II Trial of Letrozole + Ribociclib in Women with Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum: A GOG Foundation Study. SGO (2023) abstract 10 |