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 BRCA1/2 mutated ovarian cancer; ≤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 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