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BGB 3111 in Combination With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies

This study is currently recruiting participants.
Verified August 2016 by BeiGene
Sponsor:
ClinicalTrials.gov Identifier:
NCT02569476
First Posted: October 6, 2015
Last Update Posted: September 1, 2016
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.
Information provided by (Responsible Party):
BeiGene
  Purpose
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with obinutuzumab in subjects with B-cell lymphoid malignancies.

Condition Intervention Phase
B-cell Lymphoid Malignancies Drug: BGB-3111 and Obinutuzumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies

Resource links provided by NLM:


Further study details as provided by BeiGene:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: From first dose to withhin 28 days of last dose of BGB-3111 ]

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

Estimated Enrollment: 86
Study Start Date: December 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGB-3111 and obinutuzumab
In the dose-escalation part, the dose levels and regimens will be evaluated. In the indication-specific expansion cohorts, patients will be assigned to different cohorts based on histology type.
Drug: BGB-3111 and Obinutuzumab

  Eligibility

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.


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

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 >40x10^9/L (may be post-transfusion); absolute neutrophil count >1.0x10^9/L (growth factor use is allowed to bring pre-treatment neutrophils to >1.0x10^9 cells/L if marrow infiltration is involved).
    • Hepatic: Total bilirubin <3 x upper limit normal (ULN); and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3xULN.
    • Renal: Creatinine clearance ≥50 mL/min (as estimated by the Cockcroft Gault equation or as measured by nuclear medicine scan or 24 hour urine collection); subjects requiring hemodialysis will be excluded.
  • Anticipated survival of at least 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Female subjects of childbearing potential and non-sterile males must agree to practice at least one of the following methods of birth control with partner(s) throughout the study and for ≥3 months after discontinuing BGB-3111 or ≥18 months following obinutuzumab treatment, whichever is longer: total abstinence from sexual intercourse, double barrier contraception, intra uterine device (IUD) or hormonal contraceptive initiated at least 3 months prior to first administration of study drug.
  • Male subjects must not donate sperm from first study drug administration, until 3 months after BGB-3111 discontinuation or 18 months following obinutuzumab treatment, whichever is longer.

Exclusion Criteria:

  • Known central nervous system lymphoma or leukemia.
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
  • History of significant cardiovascular disease.
  • Severe or debilitating pulmonary disease.
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy.
  • Prior BTK inhibitor treatment.
  • Using medications which are strong cytochrome P450 (CYP) 3A inhibitors and strong CYP3A inducers.
  • Vaccination with a live vaccine within 28 days of the initiation of treatment.
  • Allogeneic stem cell transplantation within 6 months, or has active graft versus host disease (GvHD) requiring ongoing immunosuppression.
  • Receipt of the following treatment prior to first administration of BGB 3111, corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 3 weeks, monoclonal antibody within 4 weeks.
  • Participate in any investigational drug study within 28 days of study entry, or not recovered from non-hematologic toxicity of any prior chemotherapy up to ≤ Grade 1 (except for alopecia).
  • History of other active malignancies within 2 years of study entry.
  • Major surgery in the past 4 weeks.
  • Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with human immunodeficiency virus (HIV), human T cell lymphotropic virus (HTLV 1) seropositive status.
  • Inability to comply with the study procedures.
  • Pregnant or nursing women.
  • Any illness or condition that in the opinion of the investigator may affect the safety of treatment or evaluation of any study's endpoints.
  Contacts and Locations
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): NCT02569476


Contacts
Contact: Eric Hedrick, MD clinicaltrials@beigene.com

Locations
United States, Florida
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists Recruiting
St. Petersburg, Florida, United States, 33705
United States, Tennessee
Tennessee Oncology, PLLC - Nashville Recruiting
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Border Medical Oncology Recruiting
Albury, New South Wales, Australia, 2640
St George Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia Recruiting
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
St Vincent's Hospital Melbourne Recruiting
East Melbourne, Victoria, Australia, 3002
University Hospital Geelong Recruiting
Geelong, Victoria, Australia, 3220
St Frances Xavier Cabrini Hospital Recruiting
Malvern, Victoria, Australia, 3144
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3181
Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
BeiGene
  More Information

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT02569476     History of Changes
Other Study ID Numbers: BGB-3111_GA101_Study_001
First Submitted: September 18, 2015
First Posted: October 6, 2015
Last Update Posted: September 1, 2016
Last Verified: August 2016

Keywords provided by BeiGene:
BGB-3111
Obinutuzumab
B-cell
Lymphoma
Leukemia
Therapeutic uses

Additional relevant MeSH terms:
Neoplasms
Obinutuzumab
Antineoplastic Agents