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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 : Completed
First Posted : January 21, 2015
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE January 9, 2015
First Posted Date  ICMJE January 21, 2015
Last Update Posted Date May 19, 2021
Actual Study Start Date  ICMJE November 26, 2014
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
Number of participants with adverse events [ Time Frame: Screening to 28 days after last dose of study drug ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • 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 ]
  • Area under the plasma concentration-time curve from time 0 to infinity time (AUC∞) [ Time Frame: During first 2 weeks ]
  • Maximum plasma concentration (Cmax) [ Time Frame: During first 2 weeks ]
  • Time to reach maximum plasma concentration (tmax) [ Time Frame: During first 2 weeks ]
  • Terminal elimination half-life (t1/2) [ Time Frame: During first 2 weeks ]
  • BTK inhibition activity of BGB-3111 by measurement of free BTK [ Time Frame: During first 2 weeks ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • 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 ]
  • Area under the plasma concentration-time curve from time 0 to infinity time (AUC∞) [ Time Frame: During first 2 weeks ]
  • Maximum plasma concentration (Cmax) [ Time Frame: During first 2 weeks ]
  • Time to reach maximum plasma concentration (tmax) [ Time Frame: During first 2 weeks ]
  • Terminal elimination half-life (t1/2) [ Time Frame: During first 2 weeks ]
  • BTK inhibition activity of BGB-3111 by measurement of free BTK [ Time Frame: During first 2 weeks ]
  • Tumor response [ Time Frame: Every 3 months 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-cell Malignancies
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: BGB-3111
All patients will undertake 160MG BID of BGB-3111.
Intervention: Drug: BGB-3111
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2019)
397
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2015)
75
Actual Study Completion Date  ICMJE March 31, 2021
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Italy,   Korea, Republic of,   New Zealand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02343120
Other Study ID Numbers  ICMJE BGB-3111-AU-003
2016-003364-39 ( EudraCT Number )
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Constantine Tam, MD Peter MacCallum Cancer Centre, Australia
PRS Account BeiGene
Verification Date May 2021

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