| Trial ID # | NCT03314740; BAROCCO |
| Phase | II |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Olaparib |
| Alternate Drug Names | AZD2281, Lynparza |
| Drugs in Trial | Cediranib, Olaparib |
| Eligible Participant | Platinum resistant ovarian cancer |
| Patients Enrolled | 123 (median Pt-free interval 1.8 months; 59% of patients had > 3 prior therapies) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Randomized |
| Endpoints | PFS, evaluated per RECIST |
| Biomarkers | Exploratory: BRCA status |
| Efficacy | Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac: PFS: 5.6 vs 3.8 vs 3.1 months, HR: 0.76 (0.50-1.14, p = 0.27); HR:1.03 (0.68-1.55, p = 0.90) Exploratory analysis: |
| Clinically Significant Adverse Events | Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac: |
| Conclusion | The combination of olaparib and cediranib is not superior to chemotherapy in terms of PFS in heavily pretreated platinum resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population |
| Reference | Colombo N et al. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer. Gynecol Oncol (2022) 164(3):505-513 |