NCT04042376 · OUTCOME

Plasma Concentration of Ibrutinib

A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM) · Source last updated 2025-05-25

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

Measure: MEAN
Unit: Nanograms per milliliter (ng/mL)
Interval / dispersion: Standard Deviation
Time frame: Pre-dose on Day 1 of Weeks 1, 5 and 9

What was measured

Plasma concentrations of ibrutinib were reported.

Analysis population: Pharmacokinetics (PK) evaluable analysis set included all enrolled participants who received at least 1 dose of ibrutinib and had at least 1 available PK sample after treatment. Here, 'n' (number analyzed) signifies number of participants evaluable for specified time point.

Groups in this outcome

Ibrutinib 420 mg

Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.

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
Ibrutinib 420 mg	17

Reported measurements

Predose Day 1 Week 1

Analysis denominator · Participants

Group	Source count
Ibrutinib 420 mg	16

Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ibrutinib 420 mg	NA	NA	Not reported	Not reported	Here, 'NA' signifies that mean and standard deviation could not be calculated as concentration was below quantification limit (\<0.500 ng/mL).

Predose Day 1 Week 5

Analysis denominator · Participants

Group	Source count
Ibrutinib 420 mg	16

Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ibrutinib 420 mg	3.46	3.97	Not reported	Not reported	Not reported

Predose Day 1 Week 9

Analysis denominator · Participants

Group	Source count
Ibrutinib 420 mg	17

Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ibrutinib 420 mg	6.27	8.36	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Here, 'NA' signifies that mean and standard deviation could not be calculated as concentration was below quantification limit (\<0.500 ng/mL).
group Id
OG000
spread
NA
value
NA
denoms
counts
group Id
OG000
value
16
units
Participants
title
Predose Day 1 Week 1
categories
measurements
group Id
OG000
spread
3.97
value
3.46
denoms
counts
group Id
OG000
value
16
units
Participants
title
Predose Day 1 Week 5
categories
measurements
group Id
OG000
spread
8.36
value
6.27
denoms
counts
group Id
OG000
value
17
units
Participants
title
Predose Day 1 Week 9

denoms

counts
group Id
OG000
value
17
units
Participants

description

Plasma concentrations of ibrutinib were reported.

dispersion Type

Standard Deviation

groups

description
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
id
OG000
title
Ibrutinib 420 mg

param Type

MEAN

population Description

Pharmacokinetics (PK) evaluable analysis set included all enrolled participants who received at least 1 dose of ibrutinib and had at least 1 available PK sample after treatment. Here, 'n' (number analyzed) signifies number of participants evaluable for specified time point.

reporting Status

POSTED

time Frame

Pre-dose on Day 1 of Weeks 1, 5 and 9

title

Plasma Concentration of Ibrutinib

type

SECONDARY

unit Of Measure

Nanograms per milliliter (ng/mL)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice