NCT02657889 · OUTCOME

Phase 1: AUC,ss of Major Metabolite of Niraparib (M1)

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 major metabolite of Niraparib (M1) 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

Group	Source count
Phase 1: Niraparib 200 mg + Pembrolizumab	1
Phase 1: Niraparib 300 mg + Pembrolizumab	1

Reported measurements

Source class 1

Values in Hour*nanograms per milliliter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Niraparib 200 mg + Pembrolizumab	32878.205	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for single participant.
Phase 1: Niraparib 300 mg + Pembrolizumab	127430.14	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for single participant.

Complete source fields

classes

categories
measurements
comment
NA indicates that standard deviation could not be calculated for single participant.
group Id
OG000
spread
NA
value
32878.205
comment
NA indicates that standard deviation could not be calculated for single participant.
group Id
OG001
spread
NA
value
127430.14

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
1
units
Participants

description

Blood samples were collected at indicated time points. Pharmacokinetic analysis of major metabolite of Niraparib (M1) was conducted using standard non-compartmental analysis.

dispersion Type

Standard Deviation

groups

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
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,ss of Major Metabolite of Niraparib (M1)

type

SECONDARY

unit Of Measure

Hour*nanograms per milliliter

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

Preserved source evidence · Not medical advice