NCT04551963 is a Phase 1 clinical trial of Zanubrutinib in B-cell Malignancies, sponsored by BeiGene.

Who is sponsoring NCT04551963?

NCT04551963 is sponsored by BeiGene.

What drugs are being tested in NCT04551963?

Interventions in NCT04551963: Zanubrutinib, Fluconazole, Diltiazem, Voriconazole, Clarithromycin.

What condition does NCT04551963 study?

NCT04551963 studies B-cell Malignancies.

Is NCT04551963 still recruiting?

NCT04551963 is currently completed. Last updated 26 October 2024.

Are results published for NCT04551963?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-26 · How we verify

NCT04551963

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies

Completed Phase 1 Results posted Last updated 26 October 2024

What this trial tests

Phase 1 trial testing Zanubrutinib in B-cell Malignancies in 26 participants. Completed in 21 February 2022.

Timeline

15 November 2020

Primary endpoint
21 February 2022

21 February 2022

Quick facts

Lead sponsor	BeiGene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	15 November 2020
Primary completion	21 February 2022
Estimated completion	21 February 2022
Sites	7 locations across Australia

Drugs / interventions tested

Zanubrutinib (ZANUBRUTINIB) — full drug profile →
Fluconazole (fluconazole) — full drug profile →
Diltiazem (diltiazem) — full drug profile →
Voriconazole — full drug profile →
Clarithromycin (clarithromycin) — full drug profile →

Conditions studied

B-cell Malignancies — all drugs for B-cell Malignancies →

Sponsor

BeiGene — full company profile →

Who can join

18 and older, any sex, with B-cell Malignancies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study was to assess the steady-state zanubrutinib pharmacokinetics (PK) when co-administered with moderate and strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitors.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Zanubrutinib

Trials testing the same drug.

NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR · Phase 2 · not yet recruiting
NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel · Phase 1 · recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting

Other recruiting trials for B-cell Malignancies

Currently open trials in the same condition.

NCT07349849 — Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies · EARLY_PHASE1 · recruiting
NCT03125577 — Combination CAR-T Cell Therapy Targeting Hematological Malignancies · Phase 1, PHASE2 · recruiting
NCT03050190 — A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies · Phase 1, PHASE2 · recruiting
NCT06958679 — Evaluation of SYS6005 in Patients With Advanced Malignant Tumor · Phase 1 · recruiting
NCT06542250 — A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R · Phase 1, PHASE2 · recruiting

Other BeiGene trials

Trials by the same sponsor.

NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob · Phase 4 · recruiting
NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum · Phase 2 · active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB- · Phase 1 · active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04551963 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 26 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04551963.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing