Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma.

ABSTRACT:

Purpose

BRCA-associated cancers have increased sensitivity to poly(ADP-ribose) polymerase inhibitors (PARPis). This single arm, non-randomised, multicentre phase II trial evaluated the response rate of veliparib in patients with previously treated BRCA1/2- or PALB2-mutant pancreatic adenocarcinoma (PDAC).

Methods

Patients with stage III/IV PDAC and known germline BRCA1/2 or PALB2 mutation, 1-2 lines of treatment, Eastern Cooperative Oncology Group 0-2, were enrolled. Veliparib was dosed at a volume of 300 mg twice-daily (N = 3), then 400 mg twice-daily (N = 15) days 1-28. The primary end-point was to determine the response rate of veliparib; secondary end-points included progression-free survival (PFS), duration of response, overall survival (OS) and safety.

Results

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SUBMITTER: Lowery MA 

PROVIDER: S-EPMC7351022 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature