Download NCT01891344 A Phase 2, Open-Label Study of Rucaparib in

NCT01891344
Phase
Drug Class
Drug Name
Alternate Drug Names
Eligible Participant
Patients Enrolled
Therapy Setting
Study Design
Endpoints
Biomarkers
Efficacy
Clinically Significant
Adverse Events
Conclusion
Reference
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)
II
PARP Inhibitor
Rucaparib
CO-338, PF-01367338, AG014699
Platinum-sensitive, relapsed high grade serous or endometrioid cancer patients; no prior PARP inhibitor
treatment
180
Recurrence; Maintenance
Randomized
Progression-Free Survival (PFS) and Overall Response Rate (ORR) by RECIST in BRCAmut, BRCA-like,
biomarker negative sub-groups
BRCA1/2 status; Exploratory study of responses in patients with molecular HRD signature; associated w/ loss
of heterozygosity (LOH)
PFS: data not yet available
ORR: 38% all patients (Interim analysis: 11/20/14; 33% maturity)
Exploratory sub-group analysis
BRCA mutant:
ORR: (61-70%)
BRCA WT/high genomic LOH biomarker:
ORR: (32-40%)
BRCA WT/without genomic LOH biomarker:
ORR: (8%)
Serious AE: none
Grade 3-4 AE: : anemia (15%), elevated liver enzymes (5%), nausea/vomiting (4%), fatigue (3%)
Improved ORR in BRCAmut and BRCA WT with molecular HRD signature (Interim analysis)
Swisher, E., Updated clinical and preliminary correlative results of ARIEL-2, a Phase 2 study to identify ovarian
cancer patients likely to respond to rucaparib. EORTC/NCI/AACR Symposium on Molecular Targets and Cancer
Therapeutics 2014, Barcelona, A215 http://www.foundationmedicine.com/wpcontent/uploads/2014/11/ARIEL2_ENA_Presentation_FINAL.pdf