Clincosm LogoSign in Get a demo

A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies

Sponsor
BeiGene (Industry)
Overall Status
No longer available
CT.gov ID
NCT04052854
Collaborator
(none)
20
Locations

Study Details

Study Description

Brief Summary

This is a multicenter expanded access study of zanubrutinib monotherapy for participants with B-cell malignancies who are ineligible to enroll into any available zanubrutinib clinical trials

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Participants With B-cell Malignancies

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Key Inclusion Criteria:

    1. Histologically confirmed diagnosis of WM with R/R disease or treatment-naive and considered by their treating physician to be unsuitable for standard chemoimmunotherapy regimens

    2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

    3. Absolute neutrophil count (ANC) ≥ 0.75 x 109/L, independent of growth factor support; and Platelet count ≥ 50 x 109/L, independent of growth factor support or transfusion within 7 days of study entry

    4. Creatinine clearance of ≥ 30 mL/min

    5. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN)

    6. Total bilirubin level ≤ 2 x ULN (unless documented Gilbert's syndrome)

    Key Exclusion Criteria:

    1. Prior exposure to a Bruton tyrosine kinase (BTK) inhibitor

    2. Evidence of disease transformation at the time of study entry

    3. Ongoing requirement for systemic corticosteroid other than systemic adrenal replacement therapy

    4. Chemotherapy given with antineoplastic intent, targeted therapy, radiation therapy or antibody-based therapy within 4 weeks of the start of study drug

    5. Ongoing toxicity of ≥ Grade 2 from prior anticancer therapy

    6. Prior or concurrent active malignancy within the past 2 years

    7. Clinically significant cardiovascular disease

    8. Unable to swallow capsules or disease significantly affecting gastrointestinal function

    9. Active fungal, bacterial and/or viral infection requiring systemic therapy

    10. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows

    11. Pregnant or lactating women

    12. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug

    13. History of severe bleeding disorder

    14. Active central nervous system (CNS) involvement by WM and/or lymphoma

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Cancer Center, PC Mobile Alabama United States 36608
    2 Eisenhower Health Rancho Mirage California United States 92270
    3 Sansum Clinic Santa Barbara California United States 93105
    4 Medical Oncology Hematology Consultants, PA Newark Delaware United States 19713
    5 Woodlands Medical Specialists, PA Pensacola Florida United States 32503
    6 Medical Oncology & Hematology Associates Des Moines Iowa United States 50309
    7 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    8 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    9 Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley Las Vegas Nevada United States 89169
    10 Morristown Medical Center Morristown New Jersey United States 07960
    11 Clinical Research Alliance Lake Success New York United States 11042
    12 Mount Sinai New York New York United States 10029
    13 Gabrail Cancer Center Research Canton Ohio United States 44718
    14 Consultants in Medical Oncology and Hematology, P.C. Horsham Pennsylvania United States 19044
    15 Charleston Oncology, P.A. Charleston South Carolina United States 29414
    16 Texas Oncology, P.A. Amarillo Texas United States 79106
    17 Texas Oncology, P.A. Austin Texas United States 78705
    18 Texas Oncology, P.A. Bedford Texas United States 76022
    19 Texas Oncology-McAllen South Second Street McAllen Texas United States 78503
    20 Texas Oncology - Tyler Tyler Texas United States 75702

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Rainer Brachmann, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04052854
    Other Study ID Numbers:
    • BGB-3111-216
    First Posted:
    Aug 12, 2019
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021
    Keywords provided by BeiGene
    WM
    Treatment naive
    Relapsed/refractory
    Additional relevant MeSH terms:
    Waldenstrom Macroglobulinemia
    Zanubrutinib

    Study Results

    No Results Posted as of Jun 10, 2021