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

Completed · Phase 1

Conditions studied: Ovarian Neoplasms, Neoplasms, Solid Tumor, Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT03359850

Run by

Tesaro, Inc.

People needed

17

Starts

2018-02-20

Expected to finish

2020-06-24

Last updated by the study team

2021-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis and Criteria for Inclusion:
• All patients:
• To be considered eligible to participate in this study, all of the following requirements must be met:
• Patient, male or female, is at least 18 years of age.
• Patient has a diagnosis of advanced solid malignancy that has failed standard therapy or for which standard therapy is not likely to provide meaningful benefit, or patient has refused standard therapy.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Patient is able to take oral medications.
• Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours prior to taking study drug and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment, or be of non-childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):
• ≥45 years of age and has not had menses for > 1 year.
• Amenorrheic for < 2 years without a hysterectomy Post hysterectomy, bilateral oophorectomy, or tubal ligation..
• Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
• Male patient agrees to use an adequate method of contraception starting with the first dose of study treatment through 120 days after the last dose of study treatment..
• Patient is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
• Patients with normal hepatic function (Group 1):
• Patients screened for the normal hepatic function group must meet the following additional criteria to be eligible for enrollment:
• Patient has no history of hepatic impairment.
• Patient has liver function test (LFT) results within normal range:
• Total bilirubin ≤ ULN
• Aspartate aminotransferase (AST) ≤ ULN.
• INR ≤1.5 X ULN unless the patient is receiving anticoagulant therapy and the INR is within therapeutic range of intended use of anticoagulants.
• Patient has adequate hematologic and renal function as defined below:
• Absolute neutrophil count ≥1500/µL
• Platelets ≥100,000/µL
• Hemoglobin ≥9 g/dL
• Serum creatinine ≤1.5 × ULN or a calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation.

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Aurora, Colorado, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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