B-cell MalignanciesPhase 1NCT04551963

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

A Phase 1 study testing Zanubrutinib, Fluconazole and Diltiazem in people with B-cell Malignancies, run by BeiGene at 7 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: B-cell Malignancies
What is being tested?: Zanubrutinib, Fluconazole and Diltiazem
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 7 sitesAustralia
Study dates: 15 Nov 2020to 21 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed CLL/SLL, MCL, WM, or MZL.
Relapsed or refractory disease after at least 1 prior line of systemic therapy. Participants with MZL are required to have failed an anti-CD20 monoclonal antibody-containing chemotherapy regimen.
Baseline Eastern Cooperative Oncology Group performance status of 0 to 1.
Meet protocol guidelines for adequate bone marrow, kidney, liver, and cardiac function.

Who cannot join

Requirement of chronic treatment with strong and moderate CYP3A inhibitors or inducers or with drugs that are not allowed to be used in combination with diltiazem, clarithromycin, fluconazole, or voriconazole.
History of stroke or intracranial hemorrhage (within 6 months of treatment start).
Known hypersensitivity or contraindication to zanubrutinib, diltiazem, clarithromycin, fluconazole, or voriconazole.
Prior exposure to zanubrutinib or other Bruton tyrosine kinase inhibitor
Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Australia7 sites

Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford PK, South Australia, 5042
Monash Health
Clayton, Victoria, 3168
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Peninsula Private Hospital
Frankston, Victoria, 3199
Linear Clinical Research
Nedlands, Western Australia, 6009
John Flynn Private Hospital
Tugun, Queensland, 4224

Other trials in Australia

About this study

Official title: A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies

Conditions: B-cell Malignancies
Being tested: Zanubrutinib, Fluconazole, Diltiazem, Voriconazole, Clarithromycin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZanubrutinibDrug
Also called BGB-3111, BRUKINSA
Capsules administered at a dose and frequency as specified in the treatment arm
FluconazoleDrug
Capsules administered at a dose and frequency as specified in the treatment arm
DiltiazemDrug
Capsules administered at a dose and frequency as specified in the treatment arm
VoriconazoleDrug
Capsules administered at a dose and frequency as specified in the treatment arm
ClarithromycinDrug
Capsules administered at a dose and frequency as specified in the treatment arm

Study groups in NCT04551963
Study group	Role	What they receive
Arm A: Zanubrutinib with or without Moderate CYP3A	Experimental	Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, fluconazole was administered once a day at a dose of 400 mg with zanubrutinib at a reduced dose of 80 mg twice a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg twice a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, diltiazem was administered once a day at a dose of 180 mg with 80 mg zanubrutinib twice a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg twice a day. Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day. Receives: Drug: Zanubrutinib; Drug: Fluconazole; Drug: Diltiazem
Arm B: Zanubrutinib with or without Strong CYP3A	Experimental	Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, voriconazole was administered twice a day at a dose of 200 mg (total daily dose of 400 mg) with zanubrutinib at a reduced dose of 80 mg once a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg once a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, clarithromycin was administered twice a day at a dose of 250 mg (total daily dose of 500 mg) with 80 mg zanubrutinib once a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg once a day. Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day. Receives: Drug: Zanubrutinib; Drug: Voriconazole; Drug: Clarithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm A: Maximum Observed Concentration (Cmax)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Maximum Observed Concentration (Cmax)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm A: Time of the Maximum Observed Concentration (Tmax)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Time of the Maximum Observed Concentration (Tmax)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm A: Apparent Terminal Elimination Half-life (t1/2)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Apparent Terminal Elimination Half-life (t1/2)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)

Secondary outcomes (1)

Number of Participants Experiencing Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinical laboratory tests
Measured: From the date of first study drug administration to 30 days after last dose (up to approximately 15 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202021 Feb 2022

First posted16 Sep 2020
Study start15 Nov 2020
Primary completion21 Feb 2022
Study completion21 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for B-cell MalignanciesStudies of the same condition, open and under way.
More trials run by BeiGeneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04551963
Sponsor's protocol ID: BGB-3111-113
Status last verified: Oct 2024
First submitted: 9 Sep 2020
Last updated: 26 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

Tariq B, Ou YC, Stern JC, Mundra V, Wong Doo N, Walker P, Lewis KL, Lin C, Novotny W, Sahasranaman S, Opat S. A phase 1, open-label, randomized drug-drug interaction study of zanubrutinib with moderate or strong CYP3A inhibitors in patients with B-cell malignancies. Leuk Lymphoma. 2023 Feb;64(2):329-338. doi: 10.1080/10428194.2022.2150820. Epub 2022 Dec 8.
PubMed 36480811

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All B-cell Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies
ClinicalTrials.gov ID: NCT04551963
Acronym / sponsor ID: BGB-3111-113
Conditions: B-cell Malignancies
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: BeiGeneIndustry (pharma, biotech, devices)
Study start: 15 Nov 2020 (actual)
Primary completion: 21 Feb 2022 (actual)
Study completion: 21 Feb 2022 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 27 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: Zanubrutinib with or without Moderate CYP3A	Experimental	Drug: Zanubrutinib, Drug: Fluconazole, Drug: DiltiazemCycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, fluconazole was administered once a day at a dose of 400 mg with zanubrutinib at a reduced dose of 80 mg twice a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg twice a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, diltiazem was administered once a day at a dose of 180 mg with 80 mg zanubrutinib twice a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg twice a day. Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day.
Arm B: Zanubrutinib with or without Strong CYP3A	Experimental	Drug: Zanubrutinib, Drug: Voriconazole, Drug: ClarithromycinCycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, voriconazole was administered twice a day at a dose of 200 mg (total daily dose of 400 mg) with zanubrutinib at a reduced dose of 80 mg once a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg once a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, clarithromycin was administered twice a day at a dose of 250 mg (total daily dose of 500 mg) with 80 mg zanubrutinib once a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg once a day. Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histologically or cytologically confirmed CLL/SLL, MCL, WM, or MZL.
Relapsed or refractory disease after at least 1 prior line of systemic therapy. Participants with MZL are required to have failed an anti-CD20 monoclonal antibody-containing chemotherapy regimen.
Baseline Eastern Cooperative Oncology Group performance status of 0 to 1.
Meet protocol guidelines for adequate bone marrow, kidney, liver, and cardiac function.

Key exclusion criteria (6 listed)

Requirement of chronic treatment with strong and moderate CYP3A inhibitors or inducers or with drugs that are not allowed to be used in combination with diltiazem, clarithromycin, fluconazole, or voriconazole.
History of stroke or intracranial hemorrhage (within 6 months of treatment start).
Known hypersensitivity or contraindication to zanubrutinib, diltiazem, clarithromycin, fluconazole, or voriconazole.
Prior exposure to zanubrutinib or other Bruton tyrosine kinase inhibitor
Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZanubrutinibAlso: BGB-3111, BRUKINSACapsules administered at a dose and frequency as specified in the treatment arm	Drug	Arm A: Zanubrutinib with or without Moderate CYP3A, Arm B: Zanubrutinib with or without Strong CYP3A
FluconazoleCapsules administered at a dose and frequency as specified in the treatment arm	Drug	Arm A: Zanubrutinib with or without Moderate CYP3A
DiltiazemCapsules administered at a dose and frequency as specified in the treatment arm	Drug	Arm A: Zanubrutinib with or without Moderate CYP3A
VoriconazoleCapsules administered at a dose and frequency as specified in the treatment arm	Drug	Arm B: Zanubrutinib with or without Strong CYP3A
ClarithromycinCapsules administered at a dose and frequency as specified in the treatment arm	Drug	Arm B: Zanubrutinib with or without Strong CYP3A

Primary outcome

Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm A: Maximum Observed Concentration (Cmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Maximum Observed Concentration (Cmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm A: Time of the Maximum Observed Concentration (Tmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Time of the Maximum Observed Concentration (Tmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm A: Apparent Terminal Elimination Half-life (t1/2)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)
Arm B: Apparent Terminal Elimination Half-life (t1/2)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)

1 secondary outcome

Number of Participants Experiencing Adverse Events (AEs)
Time frame: From the date of first study drug administration to 30 days after last dose (up to approximately 15 months)

Results and safety

Results posted to the registry on 27 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Zanubrutinib With or Without Moderate CYP3A	13	11
Arm B: Zanubrutinib With or Without Strong CYP3A	13	12

Primary outcome: Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t)

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle). Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Arm A: Zanubrutinib With or Without Moderate CYP3A n = 13
Zanubrutinib 320 mg QD	1899.32 (44.95)
Zanubrutinib 80 mg BID + 400 mg fluconazole QD	921.63 (45.80)
Zanubrutinib 80 mg BID + 180 mg diltiazem QD	797.87 (43.05)

Arm A: Zanubrutinib With or Without Moderate CYP3A: Ratio of geometric least squares mean: 0.49 (90% CI 0.42 to 0.56)
Arm A: Zanubrutinib With or Without Moderate CYP3A: Ratio of geometric least squares mean: 0.42 (90% CI 0.34 to 0.51)

Population analysed: The pharmacokinetic (PK) analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).

Primary outcome: Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t)

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle). Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Arm B: Zanubrutinib With or Without Strong CYP3A n = 13
Zanubrutinib 320 mg QD	1550.40 (49.20)
Zanubrutinib 80 mg QD + 200 mg voriconazole BID	1254.29 (22.36)
Zanubrutinib 80 mg QD + 250 mg clarithromycin BID	763.00 (54.79)

Arm B: Zanubrutinib With or Without Strong CYP3A: Ratio of geometric least squares mean: 0.81 (90% CI 0.66 to 0.99)
Arm B: Zanubrutinib With or Without Strong CYP3A: Ratio of geometric least squares mean: 0.49 (90% CI 0.41 to 0.58)

Population analysed: The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).

Primary outcome: Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h)

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle). Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Arm A: Zanubrutinib With or Without Moderate CYP3A n = 12
Zanubrutinib 320 mg QD	2035.32 (46.97)
Zanubrutinib 80 mg BID + 400 mg fluconazole QD	1911.93 (46.97)
Zanubrutinib 80 mg BID + 180 mg diltiazem QD	1653.07 (44.88)

Arm A: Zanubrutinib With or Without Moderate CYP3A: Ratio of geometric least squares mean: 0.94 (90% CI 0.82 to 1.08)
Arm A: Zanubrutinib With or Without Moderate CYP3A: Ratio of geometric least squares mean: 0.81 (90% CI 0.66 to 0.99)

Population analysed: The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).

Primary outcome: Arm B: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h)

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle). Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Arm B: Zanubrutinib With or Without Strong CYP3A n = 12
Zanubrutinib 320 mg QD	1578.12 (49.53)
Zanubrutinib 80 mg QD + 200 mg voriconazole BID	1376.02 (25.09)
Zanubrutinib 80 mg QD + 250 mg clarithromycin BID	766.71 (60.44)

Arm B: Zanubrutinib With or Without Strong CYP3A: Ratio of geometric least squares mean: 0.83 (90% CI 0.65 to 1.06)
Arm B: Zanubrutinib With or Without Strong CYP3A: Ratio of geometric least squares mean: 0.48 (90% CI 0.40 to 0.58)

Population analysed: The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the date of first study drug administration to 30 days after last dose (up to approximately 15 months). Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Zanubrutinib With or Without Moderate CYP3A	3 of 13 (23.1%)	12 of 13 (92.3%)	1 of 13
Arm B: Zanubrutinib With or Without Strong CYP3A	1 of 13 (7.7%)	12 of 13 (92.3%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36480811Tariq B, Ou YC, Stern JC, Mundra V, Wong Doo N, Walker P, Lewis KL, Lin C, Novotny W, Sahasranaman S, Opat S. A phase 1, open-label, randomized drug-drug interaction study of zanubrutinib with moderate or strong CYP3A inhibitors in patients with B-cell malignancies. Leuk Lymphoma. 2023 Feb;64(2):329-338. doi: 10.1080/10428194.2022.2150820. Epub 2022 Dec 8.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

BeiGene

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zanubrutinib, Fluconazole and Diltiazem in people with B-cell Malignancies, run by BeiGene at 7 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) (time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551963, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.