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 | Recurrent high grade ovarian cancer |
Patients Enrolled | 193 platinum resistant/refractory |
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 | BRCA MUT (n=64) vs BRCA WT LOH high (n=73) vs BRCA WT LOH low (n=56): ORR: 23.4 vs 4.1 vs 5.4% |
Clinically Significant Adverse Events | Serious AE: none |
Conclusion | In platinum resistant patients rucaparib is most effective in patients that have BRCA1/2 mutations |
Reference | 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 |