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A Study to Investigate BGB-3111 in Chinese Patients With B-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03189524
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:

This phase I clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of BTK inhibitor BGB-3111 in Chinese patients with B-cell lymphoma, by conducting in two stages, the first stage being the safety assessment of dose, and the second stage being the dose expansion.

Part I: Safety evaluation - according to the results of preclinical toxicological trials and the results of the phase I clinical study conducted in Australia and New Zealand, two regimens of BGB-3111 320 mg daily (160 mg BID, administered in the morning and at night, or 320 mg QD) and "3+3" design is adopted for the assessment. The recommended dose and method of administration of phase II clinical study will be determined according to the Part I results.

Part II: Dose expansion - this stage is to further evaluate the preliminary anti-tumor effects of BGB-3111 in Chinese subjects with follicular lymphoma (FL) or marginal zone lymphoma (MZL), approximately 20 subjects with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) will be enrolled. The recommended Phase 2 dose will be used in the Part II.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study to Investigate the Safety, Tolerability and Pharmacokinetics/ Pharmacodynamics of BTK Inhibitor BGB-3111 in Chinese Patients With B-cell Lymphoma
Actual Study Start Date : July 5, 2016
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: BGB-3111
Two regimens of BGB-3111 320 mg daily (160 mg BID, administered in the morning and at night, or 320 mg QD) and "3+3" design is adopted for the study Part I to determine RP2D. The RP2D determined will be used in Part II to further evaluate the preliminary anti-tumor effects of BGB-3111 in Chinese subjects with follicular lymphoma (FL) or marginal zone lymphoma (MZL)
Drug: BGB-3111



Primary Outcome Measures :
  1. The safety and tolerability of BGB-3111 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE4.03 grading criteria in Part I [ Time Frame: Up to 5 years ]
  2. The efficacy measured by overall response rate (ORR) in Part II [ Time Frame: Up to 5 years ]
  3. The efficacy measured by complete response rate (CRR) in Part II [ Time Frame: Up to 5 years ]
  4. The efficacy measured by partial response rate (PRR) in Part II [ Time Frame: Up to 5 years ]
  5. The efficacy measured by progression free survival (PFS) in Part II [ Time Frame: Up to 5 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women with the age of 18-75 years
  • Subjects with B-cell lymphoma (defined by WHO classification) refractory or relapsed following at least one line of therapy
  • Judged by the investigator as requiring treatment.
  • ECOG performance status of 0-1.
  • Life expectancy of at least 4 months.
  • Adequate hematological function
  • Adequate renal function
  • Adequate liver function
  • Adequate Coagulation function
  • 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.
  • Male subjects must not donate sperm from start of study drug administration, until 90 days after discontinuation of treatment.

Exclusion Criteria:

  • With CNS involvement of the disease.
  • The pathological type of the disease has Disease transformation.
  • Has underdone allogeneic hematopoietic stem cell transplantation.
  • Has received corticosteroid anti-neoplastic treatment within 7 days before the first dose, has received radiotherapy and chemotherapy within 4 weeks before the first dose or has received treatment with monoclonal antibody within 4 weeks before the first dose.
  • Has received BTK inhibitor treatment prior to enrollment.
  • Has received chemotherapy and has not yet recovered from toxicity
  • Has received Chinese herbal medicine as anti-neoplastic therapy within 4 weeks before starting study treatment.
  • History of other malignancies within 2 years before study
  • With uncontrolled systemic infection.
  • Major surgery in the past 4 weeks.
  • With known HIV, or active hepatitis B or hepatitis C virus infection.
  • With cardiovascular disease of New York Heart Association (NYHA) Classification ≥ 3.
  • Significant ECG abnormalities
  • Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participation in the study.
  • Inability to comply with study procedures.
  • Currently taking anticoagulant drugs.
  • Currently taking potent CYP3A inhibitor or inducer
  • Had stroke or cerebral hemorrhage within 6 months before enrollment.

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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): NCT03189524


Contacts
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Contact: Chenmu Du, MD chenmu.du@beigene.com
Contact: Haijie Zhang, Bachelor's haijie.zhang@beigene.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
China, Hubei
Tongji Hospital, Tongji Medical College Huazhong Univ of Sci and Tch Recruiting
Wuhan, Hubei, China
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China
China, Tianjin
Tianjin Hematonosis Hospital Recruiting
Tianjin, Tianjin, China
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Jun Zhu, PHD Beijing Cnacer Hospital

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03189524     History of Changes
Other Study ID Numbers: BGB-3111-1002
CTR20160204 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action