Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
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