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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

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Trial Profile

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 of Trial: Phase I

Latest Information Update: 04 Sep 2023

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At a glance

  • Drugs Niraparib (Primary)
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors GlaxoSmithKline; GSK; TESARO
  • Most Recent Events

    • 21 Oct 2020 Status changed from active, no longer recruiting to completed.
    • 31 May 2020 Results characterizing niraparib pharmacokinetics (PK) and safety in pts with normal hepatic function vs. patients with moderate hepatic impairment presented at the 56th Annual Meeting of the American Society of Clinical Oncology
    • 10 Apr 2020 Planned End Date changed from 1 Sep 2020 to 2 Oct 2020.
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