Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients (NCT03359850) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
United States17 participantsStarted 2018-02-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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):
✓. 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.
✓. Patient has no history of hepatic impairment.
Exclusion criteria
✕. Patient has undergone palliative radiotherapy within 1 week of study drug administration, encompassing \>20% of the bone marrow.
✕. Patient is starting chemotherapy within 3 weeks of study drug administration.
What they're measuring
1
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Niraparib and Its Major Metabolite (M1) During PK Phase
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
2
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC 0-infinity) of Niraparib and M1 During PK Phase
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
3
Observed Maximum Plasma Concentration (Cmax) of Niraparib and M1 During PK Phase
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
4
Time to Maximum Concentration (Tmax) of Niraparib and M1 During PK Phase
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
5
Terminal Half-life (t½) of Niraparib and M1 During PK Phase
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
6
Apparent Total Body Clearance (CL/F) of Niraparib and M1 During PK Phase
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
. Patient has a known hypersensitivity to the components of niraparib or excipients
✕. Patients who received colony-stimulating factors within 2 weeks prior to the first dose of study treatment are not eligible.
✕. Patient has persistent chemotherapy associated Grade 2 or greater toxicity except for neuropathy, alopecia or fatigue.
✕. Patient has symptomatic uncontrolled brain or leptomeningeal metastases.
✕. Patient has undergone major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery.
✕. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder (other than hepatic impairment) or active, uncontrolled infection.