Trial · NCT02343120

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies

NCT02343120, Phase 1, Phase 2, Completed, BeiGene; results first posted 2022-04-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies. Trials, record NCT02343120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02343120

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
NCT number: NCT02343120
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 385 participants, actual
Lead sponsor: BeiGene
Conditions: B-cell Malignancies
Interventions: Zanubrutinib
First posted: 2015-01-21
Last updated: 2022-04-28
Other registries' IDs: eudract:2016-003364-39
Results first posted: 2022-04-27

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Part 1 and Part 2: Number of Participants With Adverse Events	Up to approximately 6 years and 7 months	Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements
Primary	Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib	Month 9	RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD
Secondary	Part 1 and Part 2: Area Under the Curve From Time 0 to the Last Sampling Time Point Within the Dose Interval (AUClast) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Secondary	Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Secondary	Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Secondary	Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib	Week 2 Day 1 pre-dose and 24 hours
Secondary	Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Secondary	Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib	Week 2 Day 1 pre-dose and 24 hours
Secondary	Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours
Secondary	Part 1 and Part 2: Apparent Clearance (CL/F) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part 1 and Part 2: Number of Participants With Adverse Events	Up to approximately 6 years and 7 months	The Safety Analysis Set included all participants who received ≥ 1 dose of study drug	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib	Month 9	The Safety Analysis Set included all participants who received ≥ 1 dose of study drug	milligrams	NUMBER
SECONDARY	Part 1 and Part 2: Area Under the Curve From Time 0 to the Last Sampling Time Point Within the Dose Interval (AUClast) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours	The pharmacokinetic (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.	nanograms/milliliters*hour	GEOMETRIC_MEAN
SECONDARY	Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours	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.	nanograms/milliliters*hour	GEOMETRIC_MEAN
SECONDARY	Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours	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.	nanograms/milliliter	GEOMETRIC_MEAN
SECONDARY	Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib	Week 2 Day 1 pre-dose and 24 hours	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.	nanograms/milliliter	GEOMETRIC_MEAN
SECONDARY	Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours	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.	Hours	MEDIAN
SECONDARY	Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib	Week 2 Day 1 pre-dose and 24 hours	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.	Hours	MEDIAN
SECONDARY	Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours	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.	Hours	GEOMETRIC_MEAN
SECONDARY	Part 1 and Part 2: Apparent Clearance (CL/F) of Zanubrutinib	Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours	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.	Liters/hour	GEOMETRIC_MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group103

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Part 1 and Part 2: Number of Participants With Adverse Events	Part 1: 40 mg QD	At least one treatment-emergent adverse event	3	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Part 1: 80 mg QD	At least one treatment-emergent adverse event	4	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Part 1: 160 mg QD	At least one treatment-emergent adverse event	5	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Parts 1 and 2: 160 mg BID	At least one treatment-emergent adverse event	274	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Parts 1 and 2: 320 mg QD	At least one treatment-emergent adverse event	94	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Part 1: 40 mg QD	Serious adverse events	1	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Part 1: 80 mg QD	Serious adverse events	2	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Part 1: 160 mg QD	Serious adverse events	3	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Parts 1 and 2: 160 mg BID	Serious adverse events	157	Participants
Part 1 and Part 2: Number of Participants With Adverse Events	Parts 1 and 2: 320 mg QD	Serious adverse events	45	Participants

1 to 10 of 103Source ClinicalTrials.gov

See all 103 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Part 1: Dose Escalation	STARTED	Part 1: 40 mg QD	3
Part 1: Dose Escalation	STARTED	Part 1: 80 mg QD	4
Part 1: Dose Escalation	STARTED	Part 1: 160 mg QD	5
Part 1: Dose Escalation	STARTED	Part 1 and Part 2: 160 mg BID	4
Part 1: Dose Escalation	STARTED	Part 1 and Part 2: 320 mg QD	1
Part 1: Dose Escalation	COMPLETED	Part 1: 40 mg QD	0
Part 1: Dose Escalation	COMPLETED	Part 1: 80 mg QD	0
Part 1: Dose Escalation	COMPLETED	Part 1: 160 mg QD	0
Part 1: Dose Escalation	COMPLETED	Part 1 and Part 2: 160 mg BID	0
Part 1: Dose Escalation	COMPLETED	Part 1 and Part 2: 320 mg QD	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events2,105

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Part 1: 40 mg QD	0	3	0
other	Anaemia	Blood and lymphatic system disorders	Part 1: 80 mg QD	1	4	1
other	Anaemia	Blood and lymphatic system disorders	Part 1: 160 mg QD	3	5	3
other	Anaemia	Blood and lymphatic system disorders	Part 1 and Part 2: 160 mg BID	39	278	64
other	Anaemia	Blood and lymphatic system disorders	Part 1 and Part 2: 320 mg QD	8	95	16
other	Increased tendency to bruise	Blood and lymphatic system disorders	Part 1: 40 mg QD	0	3	0
other	Increased tendency to bruise	Blood and lymphatic system disorders	Part 1: 80 mg QD	0	4	0
other	Increased tendency to bruise	Blood and lymphatic system disorders	Part 1: 160 mg QD	0	5	0
other	Increased tendency to bruise	Blood and lymphatic system disorders	Part 1 and Part 2: 160 mg BID	6	278	6
other	Increased tendency to bruise	Blood and lymphatic system disorders	Part 1 and Part 2: 320 mg QD	7	95	7

1 to 10 of 2,105Source ClinicalTrials.gov

See all 2,105 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 1: 40 mg QD	1	3
Total, all-cause mortality	Part 1: 80 mg QD	2	4
Total, all-cause mortality	Part 1: 160 mg QD	2	5
Total, all-cause mortality	Part 1 and Part 2: 160 mg BID	76	278
Total, all-cause mortality	Part 1 and Part 2: 320 mg QD	19	95
Total, other adverse events	Part 1: 40 mg QD	3	3
Total, other adverse events	Part 1: 80 mg QD	4	4
Total, other adverse events	Part 1: 160 mg QD	5	5
Total, other adverse events	Part 1 and Part 2: 160 mg BID	273	278
Total, other adverse events	Part 1 and Part 2: 320 mg QD	94	95

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31340982	BACKGROUND	PubMed
32698195	BACKGROUND	PubMed
34152395	DERIVED	PubMed
34915592	BACKGROUND	PubMed
35390135	DERIVED	PubMed
35900694	DERIVED	PubMed
38502198	DERIVED	PubMed
38775302	DERIVED	PubMed
39563886	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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