A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation

Trial ID #	NCT01540565
Phase	II
Drug Class	DNA Damage Repair Pathway Inhibitors: PARP
Drug Name	Veliparib
Alternate Drug Names	ABT-888
Drugs in Trial	Veliparib
Eligible Participant	Germline BRCA MUT ovarian cancer with ≤3 prior therapies; no prior PARP inhibitor treatment
Patients Enrolled	50
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, PFS, evaluated per RECIST
Biomarkers	gBRCA1/2 MUT
Efficacy	ORR: 26% (2CR, 11PR) PFS: 8.18 months Exploratory analysis Pt status: Pt-S (n=20): ORR: 35%; PFS: 11.0 months Pt-R (n=30): ORR: 20%; PFS: 5.8 months
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: fatigue (6%), nausea (4%)
Conclusion	Encouraging activity in gBRCA MUT ovarian cancer
Reference	Coleman RL et al. A phase II evaluation of the potent, highly selective PARP inhibitor veliparib in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who carry a germline BRCA1 or BRCA2 mutation - An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol (2015) 137(3):386-91 http://www.ncbi.nlm.nih.gov/pubmed/25818403