Phase I Pharmacokinetic Study of Niraparib in Chinese Patients with Epithelial Ovarian Cancer.

ABSTRACT:

Lessons learned

Pharmacokinetics characteristics of niraparib in Chinese patients were similar to those in white patients. Niraparib could be well tolerated by Chinese patients, and adverse events were manageable in this study. Population pharmacokinetics analysis indicated that baseline body weight had a modest impact on pharmacokinetics parameters of niraparib; however, it was not considered clinically important.

Background

This randomized, open-label, single-arm, phase I study was designed to investigate the pharmacokinetics (PK) and safety of niraparib in Chinese patients with epithelial ovarian cancer.

Methods

Eligible patients were randomized in a 1:1:1 ratio to receive 100, 200, or 300 mg of niraparib once daily. PK parameters were analyzed after single and mul

SUBMITTER: Zhang J 

PROVIDER: S-EPMC6964144 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature