Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a ¹⁴C-microtracer and therapeutic dose in cancer patients.

ABSTRACT:

Introduction

Niraparib (Zejula™) is a poly(ADP-ribose) polymerase inhibitor recently approved by the US Food and Drug Administration for the maintenance treatment of patients with recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The pivotal phase III clinical trial has shown improved progression-free survival in patients receiving niraparib compared with those receiving placebo.

Purpose

Since niraparib is administered orally, it is of interest to investigate the oral bioavailability (F _po) of this novel compound, which is the aim of this study.

Methods

Six patients received an oral therapeutic dose of 300 mg niraparib, followed by a 15-min

SUBMITTER: van Andel L 

PROVIDER: S-EPMC5754411 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature