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NCT02657889 · OUTCOME

Phase 1: Volume of Distribution (Vz/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
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 Vz/F of Niraparib.

Analysis population: Pharmacokinetic Analysis Set. The current PK sampling schedule made the estimation of Vz/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 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: Niraparib 200 mg + PembrolizumabNANANot reportedNot reportedNA indicates that data was not available the current PK sampling schedule made the estimation of Vz/F incalculable due to long half-life of Niraparib.
Phase 1: Niraparib 300 mg + PembrolizumabNANANot reportedNot reportedNA indicates that data was not available the current PK sampling schedule made the estimation of Vz/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 the current PK sampling schedule made the estimation of Vz/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 the current PK sampling schedule made the estimation of Vz/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 Vz/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 Vz/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: Volume of Distribution (Vz/F) of Niraparib
type
SECONDARY
unit Of Measure
Liters

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

Preserved source evidence · Not medical advice