Clinical Trials /

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies

NCT02343120

Description:

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
  • Official Title: A Phase I, 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

Clinical Trial IDs

  • ORG STUDY ID: BGB-3111-AU-003
  • SECONDARY ID: 2016-003364-39
  • NCT ID: NCT02343120

Conditions

  • B-cell Malignancies

Interventions

DrugSynonymsArms
BGB-3111BGB-3111

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
BGB-3111ExperimentalAll patients will undertake 160MG BID of BGB-3111.
  • BGB-3111

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with adverse events
Time Frame:From first dose to within 28 days of last dose of BGB-3111
Safety Issue:
Description:Creating a safety profile

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure:Area under the plasma concentration-time curve from time 0 to infinity time (AUC∞)
Time Frame:During first 2 weeks
Safety Issue:
Description:
Measure:Maximum plasma concentration (Cmax)
Time Frame:During first 2 weeks
Safety Issue:
Description:
Measure:Time to reach maximum plasma concentration (tmax)
Time Frame:During first 2 weeks
Safety Issue:
Description:
Measure:Terminal elimination half-life (t1/2)
Time Frame:During first 2 weeks
Safety Issue:
Description:
Measure:BTK inhibition activity of BGB-3111 by measurement of free BTK
Time Frame:During first 2 weeks
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:BeiGene

Last Updated

November 1, 2019