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Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

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ClinicalTrials.gov Identifier: NCT04172246
Recruitment Status : Active, not recruiting
First Posted : November 21, 2019
Last Update Posted : November 28, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:

This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies.

This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese participants with B-cell malignancies. No formal hypothesis testing will be performed given the small sample size.


Condition or disease Intervention/treatment Phase
Mature B-cell Malignancies Drug: Zanubrutinib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : October 2, 2023
Estimated Study Completion Date : October 2, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Zanubrutinib Drug: Zanubrutinib
Zanubrutinib at 160 mg orally twice daily
Other Name: BGB-3111


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  2. Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  3. Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  4. Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib [ Time Frame: Up to 29 days ]
  5. Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib [ Time Frame: Up to 29 days ]
  6. Part 2: Overall response rate as assessed by Independent Review Committee (IRC) [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever occurs first ]

Secondary Outcome Measures :
  1. Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells [ Time Frame: Predose up to 24 hours postdose ]
  2. Part 1: Overall response rate (ORR) as assessed by the investigator [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  3. Part 1: Progression-free survival (PFS) as assessed by the investigator [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  4. Part 1: Duration of response as assessed by the investigator [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  5. Part 1: Time to response as assessed by the investigator [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  6. Part 2: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  7. Part 2: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  8. Part 2: Maximum Plasma Concentration (Cmax) of zanubrutinib [ Time Frame: Predose up to 24 hours postdose Cycle 1 day 1 (C1D1) and Cycle 2 day 1 (C2D1) ]
  9. Part 2: Number of Participants Experiencing AEs Leading to Discontinuation of Treatment [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  10. Part 2: Rate of complete response for chronic lymphocytic leukemia (CLL) as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  11. Part 2: Rate of complete response with incomplete marrow for CLL as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  12. Part 2: Rate of complete response for small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM) as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  13. Part 2: Rate of very good partial response (VGPR) or better for WM as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  14. Part 2: Major response rate (partial response or better) for WM as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  15. Part 2: Rate of partial response or better for CLL as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  16. Part 2: Overall response rate (ORR) by disease type as assessed by the investigator [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  17. Part 2: Progression-free survival (PFS) as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  18. Part 2: Duration of response as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  19. Part 2: Time to response as assessed by IRC [ Time Frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier ]
  20. To assess the efficacy of zanubrutinib as measured by overall survival [ Time Frame: Overall survival defined as time from start of study treatment to death due to any cause ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Participants with Confirmed diagnosis of mature B-cell neoplasms including chronic lymphocytic leukemia/ small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma and Waldenström's macroglobulinemia
  • Relapsed/refractory disease defined as disease that relapsed after, or been refractory to, at least 1 prior therapy
  • Meeting at least one of criteria for requiring treatment
  • Measurable disease by computed tomography (CT)/ magnetic resonance imaging (MRI) for mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL) participants and by serum immunoglobulin (Ig) M level > 0.5 g/dL for WM participants
  • Eastern Cooperative Oncology Group performance status of 0, 1, or 2
  • Life expectancy of > 4 months

Key Exclusion Criteria:

  • Known central nervous system involvement by lymphoma/leukemia
  • Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
  • Prior allogeneic stem cell transplant
  • Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib
  • Active fungal, bacterial, and/or viral infection requiring systemic therapy
  • Prior therapy with B-cell receptor inhibitor (eg, Bruton tyrosine kinase, phosphoinositide 3 kinase delta, and/or spleen tyrosine kinase inhibitor) or B-cell lymphoma 2 inhibitor (eg, venetoclax/ABT-199)
  • Pregnant, lactating, or nursing women
  • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04172246


Locations
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Japan
Nagoya University Hospital
Nagoya, Aichi, Japan, 003-0804
Toyohashi Municipal Hospital
Toyohashi, Aichi, Japan, 441-8570
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan, 790-8524
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0904
Aiiku Hospital
Sapporo, Hokkaido, Japan, 064-0804
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0047
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, Japan, 240-8555
Kanagawa Cancer Center Hospital
Yokohama, Kanagawa, Japan, 241-8515
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Aomori Prefectural Central Hospital
Aomori, Japan, 030-8553
Chiba-Ken Cancer Center
Chiba, Japan, 260-8727
Gifu Municipal Hospital
Gifu, Japan, 500-8513
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, Japan, 852-8511
National Hospital Organization Okayama Medical Center
Okayama, Japan, 701-1192
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04172246    
Other Study ID Numbers: BGB-3111-111
JapicCTI-195047 ( Registry Identifier: Jape )
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
relapsed/refractory chronic lymphocytic leukemia
relapsed/refractory small lymphocytic lymphoma
treatment-naïve chronic lymphocytic leukemia
treatment-naïve /small lymphocytic lymphoma
relapsed/refractory mantle cell lymphoma
 relapsed/refractory marginal zone lymphoma
relapsed/refractory follicular lymphoma
relapsed/refractory Waldenström macroglobulinemia
treatment-naïve Waldenström macroglobulinemia
Additional relevant MeSH terms:
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Neoplasms
Zanubrutinib
Antineoplastic Agents
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action