ONC_GOG 3005 / AbbVie #M13-694

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Inclusion Criteria:

Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation.
High-grade serous adenocarcinoma
Willing to undergo testing for gBRCA.
Adequate hematologic, renal, and hepatic function.
Neuropathy (sensory and motor) less than or equal to Grade 1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a needle core biopsy confirming the histological diagnosis prior to enrollment.
Participants with measurable disease and non-measurable disease are eligible. Participants may or may not have cancer-related symptoms.
Participant has one of the following available for PD analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1.
Phase III
NCT02470585
Cancer
Gynecologic
Melissa Hardesty MD
AbbVie Inc
Susan Wildman
  • Alaska Research
  • Alaska Women's Cancer Care