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BGB-3111 in Combination With BGB-A317 in Subjects With B-cell 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02795182
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : November 27, 2017
Information provided by (Responsible Party):

Brief Summary:
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with BGB-A317 in subjects with B-cell lymphoid malignancies.

Condition or disease Intervention/treatment Phase
Lymphoma Leukemia Drug: BGB-3111 Drug: BGB-A317 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Assess Safety, Tolerability and Antitumor Activities of the Combination of BGB-3111 With BGB-A317 in Subjects With B-Cell Lymphoid Malignancies
Actual Study Start Date : February 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BGB-3111 and BGB-A317
In the dose -escalation part, the dose levels and regimens will be evaluated.
Drug: BGB-3111
Drug: BGB-A317

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From first dose to 28 days after last dose of BGB-3111 or BGB-A317 ]

Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve from time 0 to the time of the last measureable concentration (AUClast) [ Time Frame: the first 6 months ]
  2. Area under the plasma concentration-time curve from time 0 to infinity time (AUC0-infinity) [ Time Frame: the first 6 months ]
  3. Maximum plasma concentration (Cmax) [ Time Frame: the first 6 months ]
  4. Terminal elimination half-life (t1/2) [ Time Frame: the first 6 months ]
  5. BTK inhibition activity of BGB-3111 by measurement of free BTK [ Time Frame: the first 6 months ]
  6. 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

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

Inclusion Criteria:

  • Aged ≥ 18 years, able and willing to provide written informed consent and to comply with the study protocol.
  • Laboratory parameters as specified below:

    • Hematologic: platelet count > 50 x 10e9/L; absolute neutrophil count > 1.0 x109 cells/L;
    • Hepatic: total Bilirubin ≤ 1.5 times the upper limit of normal (ULN) ; and aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) ≤ 3x ULN
    • Renal: creatinine clearance ≥ 30 mL/min ; subjects requiring hemodialysis will be excluded.
  • Anticipated survival of at least 4 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • 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 ≥ 3 months after discontinuing study drugs: total abstinence from sexual intercourse, double-barrier contraception, intrauterine device or hormonal contraceptive initiated at least 3 months prior to first dose of study drugs.
  • Male subjects must not donate sperm from initial study drug administration, until 180 days after drug discontinuation.

Exclusion Criteria:

  • Known, active, central nervous system lymphoma or leukemia
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
  • History of stroke or cerebral hemorrhage within 6 months of enrollment
  • History of significant cardiovascular disease, defined as:

    • Congestive heart failure greater than New York Heart Association (NYHA) class II according to the NYHA functional classification
    • Unstable angina or myocardial infarction with 6 months of enrollment
  • Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, congestive obstructive pulmonary disease)
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • Prior Bruton's tyrosine kinase (BTK) inhibitor or anti- programmed cell death-1 (PD-1)/anti-Programmed Death Ligand-1 (PD-L1) treatment.
  • History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies
  • Vaccination with a live vaccine within 28 days of the initiation of treatment.
  • Participated in any investigational drug study within 28 days or not recovered from toxicity of any prior chemotherapy to grade ≤ 1.
  • Major surgery in the past 4 weeks
  • Active and symptomatic fungal, bacterial and/or viral infection including evidence of infection with human immunodeficiency virus (HIV), human T-cell lymphotropic virus type 1 seropositive status
  • Inability to comply with study procedures
  • Pregnant or nursing women
  • Men or women of childbearing potential who refuse to use an adequate measure of contraception unless they have past medical history of surgical sterilization.
  • Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any study's endpoints

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 identifier (NCT number): NCT02795182

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Contact: Eric Hedrick, MD

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Australia, New South Wales
Concord Hospital Recruiting
Sydney, New South Wales, Australia, 2139
Australia, Victoria
Monash Hospital Recruiting
Clayton, Victoria, Australia, 3168
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: BeiGene Identifier: NCT02795182     History of Changes
Other Study ID Numbers: BGB-3111_BGB-A317_Study_001
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by BeiGene:

Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action