NCT02657889 · OUTCOME

Phase 1: Cmin and Cmax 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: Nanogram per milliliter
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 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	7
Phase 1: Niraparib 300 mg + Pembrolizumab	7

Reported measurements

Cmin

Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Niraparib 200 mg + Pembrolizumab	42.114	42.765	Not reported	Not reported	Not reported
Phase 1: Niraparib 300 mg + Pembrolizumab	46.677	45.343	Not reported	Not reported	Not reported

Cmax

Values in Nanogram per milliliter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Niraparib 200 mg + Pembrolizumab	340.14	89.356	Not reported	Not reported	Not reported
Phase 1: Niraparib 300 mg + Pembrolizumab	491.66	226.122	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
42.765
value
42.114
group Id
OG001
spread
45.343
value
46.677
title
Cmin
categories
measurements
group Id
OG000
spread
89.356
value
340.14
group Id
OG001
spread
226.122
value
491.66
title
Cmax

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
7
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 1 Day 1 (each cycle of 21 days)

title

Phase 1: Cmin and Cmax of Major Metabolite of Niraparib (M1)

type

SECONDARY

unit Of Measure

Nanogram per milliliter

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

Preserved source evidence · Not medical advice