Skip to main content
OpenTrials
Completed

NCT Number: NCT04551963

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

B-cell Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • 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.

Treatment and study plan

Zanubrutinib

Drug

Capsules administered at a dose and frequency as specified in the treatment arm

Other names: BGB-3111, BRUKINSA

Fluconazole

Drug

Capsules administered at a dose and frequency as specified in the treatment arm

Diltiazem

Drug

Capsules administered at a dose and frequency as specified in the treatment arm

Voriconazole

Drug

Capsules administered at a dose and frequency as specified in the treatment arm

Clarithromycin

Drug

Capsules administered at a dose and frequency as specified in the treatment arm

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

Secondary outcomes

  1. 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)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinical laboratory tests

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.