A phase 1 dose-escalation study of veliparib with bimonthly FOLFIRI in patients with advanced solid tumours.

ABSTRACT:

Background

Veliparib is a potent poly(ADP-ribose) polymerase inhibitor. This phase 1 study aimed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of veliparib combined with various FOLFIRI regimens in patients with solid tumours.

Methods

Patients received veliparib (10-270 mg BID, days 1-5, 15-19) and FOLFIRI (days 1-3, 15-17) in three regimens containing 5-fluorouracil 2,400 mg/m²: irinotecan 150 mg/m² and folinic acid 400 mg/m² (part 1); irinotecan 180 mg/m², folinic acid 400 mg/m², and 5-fluorouracil 400 mg/m² bolus (part 2), or irinotecan 180 mg/m² (part 3). The RP2D was further evaluated in safety expansion cohorts. Preliminary antitumour activity was also asses

SUBMITTER: Berlin J 

PROVIDER: S-EPMC5933261 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature