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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04551963
Other study ID # BGB-3111-113
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 15, 2020
Est. completion date February 21, 2022

Study information

Verified date February 2023
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date February 21, 2022
Est. primary completion date February 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: 1. Histologically or cytologically confirmed CLL/SLL, MCL, WM, or MZL. 2. 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. 3. Baseline Eastern Cooperative Oncology Group performance status of 0 to 1. 4. Meet protocol guidelines for adequate bone marrow, kidney, liver, and cardiac function. Key Exclusion Criteria: 1. 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. 2. History of stroke or intracranial hemorrhage (within 6 months of treatment start). 3. Known hypersensitivity or contraindication to zanubrutinib, diltiazem, clarithromycin, fluconazole, or voriconazole. 4. Prior exposure to zanubrutinib or other Bruton tyrosine kinase inhibitor 5. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zanubrutinib
Capsules administered at a dose and frequency as specified in the treatment arm
Fluconazole
Capsules administered at a dose and frequency as specified in the treatment arm
Diltiazem
Capsules administered at a dose and frequency as specified in the treatment arm
Voriconazole
Capsules administered at a dose and frequency as specified in the treatment arm
Clarithromycin
Capsules administered at a dose and frequency as specified in the treatment arm

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Flinders Medical Centre Bedford Park South Australia
Australia Monash Health Clayton Victoria
Australia Concord General Repatriation Hospital Concord New South Wales
Australia Peninsula Private Hospital Frankston Victoria
Australia Linear Clinical Research Nedlands Western Australia
Australia John Flynn Private Hospital Tugun Queensland

Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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 ma — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) 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)
Primary Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) 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)
Primary Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) 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)
Primary Arm B: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) 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)
Primary Arm A: Maximum Observed Concentration (Cmax) 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)
Primary Arm B: Maximum Observed Concentration (Cmax) 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)
Primary Arm A: Time of the Maximum Observed Concentration (Tmax) 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)
Primary Arm B: Time of the Maximum Observed Concentration (Tmax) 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)
Primary Arm A: Apparent Terminal Elimination Half-life (t1/2) 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)
Primary Arm B: Apparent Terminal Elimination Half-life (t1/2) 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 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 From the date of first study drug administration to 30 days after last dose (up to approximately 15 months)
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