| Trial ID # | NCT01891344; ARIEL2 |
| Phase | II |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Rucaparib |
| Alternate Drug Names | AG-014699, PF 01367338, CO-338, Rubraca |
| Drugs in Trial | Rucaparib |
| Eligible Participant | Platinum sensitive ovarian cancer at first recurrence (ARIEL2, Part 1) |
| Patients Enrolled | 204 |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, PFS, evaluated per RECIST |
| Biomarkers | Exploratory: BRCA1/2; LOH (by FoundationFocus CDx BRCA LOH) |
| Efficacy | Data from ARIEL2, Part 1: ORR: 80 vs 29 vs 10% |
| Clinically Significant Adverse Events | Serious AE: none |
| Conclusion | Improved ORR and PFS with rucaparib treatment in BRCA MUT patients |
| Reference | Swisher EM et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol (2017) 18(1):75-87 Swisher EM et al. Characterization of patients (pts) with long-term responses to rucaparib in recurrent ovarian cancer (OC). J Clin Oncol (2020) 38: (suppl; abstr 6015) Swisher EM et al. Poster Swisher EM et al. Molecular and clinical determinants of response and resistance to rucaparib for recurrent ovarian cancer treatment in ARIEL2 (Parts 1 and 2). Nat Commun (2021) 12(1):2487 |