A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)

Trial ID # NCT01891344; ARIEL2
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Rucaparib
Alternate Drug Names Rubraca, CO-338, PF 01367338, AG-014699
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%
PFS: 7.2 vs 1.9 vs 1.8 months

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: anemia or decreased hemoglobin (22%), elevated liver enzymes (13%)

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
https://pubmed.ncbi.nlm.nih.gov/33941784/

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