NCT02343120 · OUTCOME

Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies · Source last updated 2022-04-28

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

Measure: GEOMETRIC_MEAN
Unit: nanograms/milliliters*hour
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

Analysis population: The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.

Groups in this outcome

Part 1: 40 mg QD

Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

Part 1: 80 mg QD

Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

Part 1: 160 mg QD

Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up

Part 1 and Part 2: 160 mg BID

Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.

Part 1 and Part 2: 320 mg QD

Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.

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
Part 1: 40 mg QD	3
Part 1: 80 mg QD	4
Part 1: 160 mg QD	5
Part 1 and Part 2: 160 mg BID	59
Part 1 and Part 2: 320 mg QD	18

Reported measurements

Source class 1

Values in nanograms/milliliters*hour · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: 40 mg QD	301.1	51.5	Not reported	Not reported	Not reported
Part 1: 80 mg QD	460.0	100.6	Not reported	Not reported	Not reported
Part 1: 160 mg QD	1505	52.7	Not reported	Not reported	Not reported
Part 1 and Part 2: 160 mg BID	1253	59.0	Not reported	Not reported	Not reported
Part 1 and Part 2: 320 mg QD	2538	47.8	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
51.5
value
301.1
group Id
OG001
spread
100.6
value
460.0
group Id
OG002
spread
52.7
value
1505
group Id
OG003
spread
59.0
value
1253
group Id
OG004
spread
47.8
value
2538

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
5
group Id
OG003
value
59
group Id
OG004
value
18
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
id
OG000
title
Part 1: 40 mg QD
description
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
id
OG001
title
Part 1: 80 mg QD
description
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
id
OG002
title
Part 1: 160 mg QD
description
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
id
OG003
title
Part 1 and Part 2: 160 mg BID
description
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
id
OG004
title
Part 1 and Part 2: 320 mg QD

param Type

GEOMETRIC_MEAN

population Description

The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.

reporting Status

POSTED

time Frame

Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

title

Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib

type

SECONDARY

unit Of Measure

nanograms/milliliters*hour

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

Preserved source evidence · Not medical advice