NCT03359850

Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients

An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following a Single Oral Dose in Patients With Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment, for the purpose of providing recommendations to guide the initial dose and dose titration in this patient population.

Conditions

• Ovarian Neoplasms
• Neoplasms
• Solid Tumor
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.

Timeline

• Start date: 2018-02-20
• Primary completion: 2019-09-16
• Completion: 2020-06-24
• First posted: 2017-12-02
• Last updated: 2021-05-28
• Results posted: 2020-11-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study