Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551963
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE September 9, 2020
First Posted Date  ICMJE September 16, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE November 15, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • area under plasma concentration-time curve up to the last measurable concentration (AUC0-t) [ Time Frame: Day 3, Day 10, and Day 26 of Cycle 1 (28-day cycle) ]
  • AUC from 0 to 24 hours (AUC0-24h) [ Time Frame: Day 3, Day 10, and Day 26 of Cycle 1 (28-day cycle) ]
  • maximum plasma concentration (Cmax) [ Time Frame: Day 3, Day 10, and Day 26 of Cycle 1 (28-day cycle) ]
  • time to reach the Cmax (Tmax) [ Time Frame: Day 3, Day 10, and Day 26 of Cycle 1 (28-day cycle) ]
  • apparent terminal elimination half-life (t1/2) [ Time Frame: Day 3, Day 10, and Day 26 of Cycle 1 (28-day cycle) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Number of participants experiencing Adverse Events (AEs) [ Time Frame: Up to 6 28-day cycles ]
  • Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 6 28-day cycles ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies
Official Title  ICMJE A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies
Brief Summary The primary objective of this study is to assess the steady-state zanubrutinib pharmacokinetics (PK) when coadministered with moderate and strong cytochrome P450 A (CYP3A) inhibitors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-cell Malignancies
Intervention  ICMJE
  • Drug: Zanubrutinib
    80 mg capsules administered at a dose and frequency as specified in the treatment arm
    Other Names:
    • BGB-3111
    • BRUKINSA
  • Drug: Fluconazole
    400 mg administered as 2 x 200 mg capsules once daily (QD)
  • Drug: Diltiazem
    180 mg capsule administered once daily (QD)
  • Drug: Voriconazole
    200 mg capsules administered twice daily (BID)
  • Drug: Clarithromycin
    250 mg capsules administered twice daily (BID)
Study Arms  ICMJE
  • Experimental: Zanubrutinib + Moderate CYP3A
    Cycle 1 (28 days): Zanubrutinib 80 mg twice daily (BID) + fluconazole (days 4 - 10), zanubrutinib 320 mg once daily (QD) (days 13 - 19), zanubrutinib 80 mg BID + diltiazem (days 20 - 26) Cycles 2 - 6 (28 days each): zanubrutinib 160 mg BID or 320 mg QD
    Interventions:
    • Drug: Zanubrutinib
    • Drug: Fluconazole
    • Drug: Diltiazem
  • Experimental: Zanubrutinib + Strong CYP3A
    Cycle 1 (28 days): Zanubrutinib 80 mg QD + voriconazole (days 4 - 10), zanubrutinib 320 mg QD (days 13 - 19), zanubrutinib 80 mg QD + clarithromycin (days 20 - 26) Cycles 2 - 6 (28 days each): zanubrutinib 160 mg BID or 320 mg QD
    Interventions:
    • Drug: Zanubrutinib
    • Drug: Voriconazole
    • Drug: Clarithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04551963
Other Study ID Numbers  ICMJE BGB-3111-113
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Novotny, MD BeiGene
PRS Account BeiGene
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP