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NCT02657889 · OUTCOME

Phase 1: AUC at Steady State (AUC,ss) 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
Hour*nanograms per milliliter
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and 1, 2, 4, 6, 8, 24 Hours post-dose on Cycle 2 Day 1 (each cycle of 21 days)

What was measured

Blood samples were collected at indicated time points. Pharmacokinetic analysis of Niraparib was conducted using standard non-compartmental analysis.

Analysis population: Pharmacokinetic Analysis Set. Only those participants with data available at the specified time points were analyzed.

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 + Pembrolizumab4
Phase 1: Niraparib 300 mg + Pembrolizumab2

Reported measurements

Source class 1
Values in Hour*nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: Niraparib 200 mg + Pembrolizumab27396.91015097.186Not reportedNot reportedNot reported
Phase 1: Niraparib 300 mg + Pembrolizumab30799.7429868.734Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        15097.186
        value
        27396.910
      2. group Id
        OG001
        spread
        9868.734
        value
        30799.742
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Blood samples were collected at indicated time points. Pharmacokinetic analysis of Niraparib was conducted using standard non-compartmental analysis.
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. Only those participants with data available at the specified time points were analyzed.
reporting Status
POSTED
time Frame
Pre-dose and 1, 2, 4, 6, 8, 24 Hours post-dose on Cycle 2 Day 1 (each cycle of 21 days)
title
Phase 1: AUC at Steady State (AUC,ss) of Niraparib
type
SECONDARY
unit Of Measure
Hour*nanograms per milliliter

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

Preserved source evidence · Not medical advice