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Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02343120
Recruitment Status : Active, not recruiting
First Posted : January 21, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-3111 in patients with B-Cell Lymphoid Malignancies.

Condition or disease Intervention/treatment Phase
B-cell Malignancies Drug: BGB-3111 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 397 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
Actual Study Start Date : November 26, 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: BGB-3111
All patients will undertake 160MG BID of BGB-3111.
Drug: BGB-3111

In the dose-escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.

In the safety, schedule and efficacy expansion part, patients will be assigned to different cohorts based on histology type.





Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From first dose to within 28 days of last dose of BGB-3111 ]
    Creating a safety profile


Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) [ Time Frame: During first 2 weeks ]
  2. Area under the plasma concentration-time curve from time 0 to infinity time (AUC∞) [ Time Frame: During first 2 weeks ]
  3. Maximum plasma concentration (Cmax) [ Time Frame: During first 2 weeks ]
  4. Time to reach maximum plasma concentration (tmax) [ Time Frame: During first 2 weeks ]
  5. Terminal elimination half-life (t1/2) [ Time Frame: During first 2 weeks ]
  6. BTK inhibition activity of BGB-3111 by measurement of free BTK [ Time Frame: During first 2 weeks ]
  7. Tumor response [ Time Frame: Every 12 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged ≥ 18 years, voluntarily consented to the study.
  2. WHO classification defined B-lymphoid malignancy, with the exception of Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphoma.
  3. Requirement for treatment in the opinion of the investigator.
  4. Disease which has relapsed, or is refractory, following at least one line of therapy, with no therapy of higher priority available.
  5. ECOG performance status of 0-2.
  6. Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10^9/L and platelets ≥ 50 x 10^9/L; patients with neutrophils < 1.0 x 10^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10^9/L.
  7. Adequate renal function, as defined by creatinine clearance of ≥ 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).
  8. Adequate liver function, as defined by AST and ALT ≤ 3 x ULN, and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome).
  9. INR and APTT ≤ 1.5 x ULN.
  10. Female subjects of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
  11. Male subjects must not donate sperm from initial study drug administration, until 90 days after drug discontinuation.

Exclusion Criteria:

  1. Current CNS involvement by disease
  2. Current histologically transformed disease.
  3. Prior BTK inhibitor treatment.
  4. Allogeneic stem cell transplantation within 6 months, or has active GVHD requiring ongoing immunosuppression.
  5. Receipt of the following treatment prior to first dose of BGB-3111: corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 2 weeks, monoclonal antibody within 4 weeks.
  6. Not recovered from toxicity of any prior chemotherapy to grade ≤ 1.
  7. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
  8. Uncontrolled systemic infection requiring parenteral anti-microbial therapy.
  9. Major surgery in the past 4 weeks.
  10. Known HIV, or active hep B or hep C infection (detected positive by PCR).
  11. Cardiovascular disease resulting in New York Heart Association function status of ≥ 3.
  12. Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.
  13. Inability to comply with study procedures.
  14. On medications which are CYP3A inhibitors.

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): NCT02343120


Locations
Show Show 23 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Constantine Tam, MD Peter MacCallum Cancer Centre, Australia
Publications of Results:
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT02343120    
Other Study ID Numbers: BGB-3111-AU-003
2016-003364-39 ( EudraCT Number )
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action