| Trial ID # | NCT03093155 |
| Phase | II |
| Drug Class | Chemotherapy |
| Drug Name | Ixabepilone |
| Alternate Drug Names | Ixempra, Epothilone-B, epothilone B lactam, BMS-247550, Azaepothilone B |
| Drugs in Trial | Bevacizumab, Ixabepilone |
| Eligible Participant | Platinum resistant, refractory or persistent ovarian cancer; median 3 prior therapies; 18% Pt-Rf, 55% w/ prior Bev |
| Patients Enrolled | 78 |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Randomized |
| Endpoints | ORR, PFS, OS, evaluated per RECIST |
| Efficacy | Ixa+Bev (n=39) vs Ixa (n=37): ORR: 33 vs 8%, p=0.004 |
| Clinically Significant Adverse Events | Serious AE: 1 bowel perforation in Ixa+Bev arm |
| Conclusion | Ixabepilone+bevacizumab is a well-tolerated, effective combination for treatment of platinum/taxane resistant ovarian cancer that extends both PFS/OS relative to ixabepilone monotherapy and prior receipt of bevacizumab should not preclude use of ixabepilone+bevacizumab |
| Reference | Roque DM et al. Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer. Br J Cancer (2022) 126(12):1695-1703 Roque DM et al. Randomized phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian / fallopian tube / primary peritoneal cancer (NCT03093155): updated survival and subgroup analyses. SGO 2024, Poster |