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NCT02657889 · OUTCOME

Phase 1: Apparent Oral Clearance (CL/F) of Niraparib

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer · Source last updated 2022-12-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Liters per hour
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and 1, 2, 4, 6, 8, 24 Hours post-dose on Cycle 1 Day 1 (each cycle of 21 days)

What was measured

Blood samples were planned to be collected for to determine CL/F of Niraparib.

Analysis population: Pharmacokinetic Analysis Set. The current PK sampling schedule made the estimation of CL/F incalculable due to long half life of Niraparib.

Groups in this outcome

Phase 1: Niraparib 200 mg + Pembrolizumab

Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Phase 1: Niraparib 300 mg + Pembrolizumab

Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1: Niraparib 200 mg + Pembrolizumab7
Phase 1: Niraparib 300 mg + Pembrolizumab7

Reported measurements

Source class 1
Values in Liters per hour · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: Niraparib 200 mg + PembrolizumabNANANot reportedNot reportedNA indicates that data was not available as the current PK sampling schedule made the estimation of CL/F incalculable due to long half-life of Niraparib.
Phase 1: Niraparib 300 mg + PembrolizumabNANANot reportedNot reportedNA indicates that data was not available as the current PK sampling schedule made the estimation of CL/F incalculable due to long half-life of Niraparib.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA indicates that data was not available as the current PK sampling schedule made the estimation of CL/F incalculable due to long half-life of Niraparib.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        NA indicates that data was not available as the current PK sampling schedule made the estimation of CL/F incalculable due to long half-life of Niraparib.
        group Id
        OG001
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Blood samples were planned to be collected for to determine CL/F of Niraparib.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
    id
    OG000
    title
    Phase 1: Niraparib 200 mg + Pembrolizumab
  2. description
    Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    OG001
    title
    Phase 1: Niraparib 300 mg + Pembrolizumab
param Type
MEAN
population Description
Pharmacokinetic Analysis Set. The current PK sampling schedule made the estimation of CL/F incalculable due to long half life of Niraparib.
reporting Status
POSTED
time Frame
Pre-dose and 1, 2, 4, 6, 8, 24 Hours post-dose on Cycle 1 Day 1 (each cycle of 21 days)
title
Phase 1: Apparent Oral Clearance (CL/F) of Niraparib
type
SECONDARY
unit Of Measure
Liters per hour

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice