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Trial record 6 of 28 for:    BGB-3111

Study of Evaluate Efficacy and Safety of BGB-3111 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

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: NCT03206970
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE June 29, 2017
First Posted Date  ICMJE July 2, 2017
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE March 2, 2017
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
the rate of objective response [ Time Frame: Up to 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03206970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • Progression free survival (PFS) [ Time Frame: Up to 3 years ]
  • Six-month progression-free survival rate [ Time Frame: Up to 3 years ]
  • Duration of response (DOR) [ Time Frame: Up to 3 years ]
  • Overall survival (OS) [ Time Frame: Up to 3 years ]
  • The safety and tolerability of BGB-3111, measured by the incidence, timing, and severity of AEs [ Time Frame: Up to 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • progression free survival (PFS) and Six-month progression-free survival rate [ Time Frame: Up to 3 years ]
  • Duration of response (DOR) [ Time Frame: Up to 3 years ]
  • Overall survival (OS) [ Time Frame: Up to 3 years ]
  • The safety and tolerability of BGB-3111, measured by the incidence, timing, and severity of AEs [ Time Frame: Up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Evaluate Efficacy and Safety of BGB-3111 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Official Title  ICMJE A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Refractory or Relapsed Mantle Cell Lymphoma (MCL)
Brief Summary This is a single-arm, open-label, multi-center Phase 2 study in subjects with histologically documented MCL who have no response or relapse after ≥ 1 but < 5 prior treatment regimen(s). The study is composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory Mantle Cell Lymphoma
Intervention  ICMJE Drug: BGB-3111
BGB-3111 160 mg will be administered orally BID. Daily treatment with BGB-3111 may be continued for up to 3 years until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor.
Study Arms  ICMJE Experimental: BGB-3111
Intervention: Drug: BGB-3111
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 14, 2018)
86
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2017)
80
Estimated Study Completion Date  ICMJE November 2020
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnostic report has to include evidence for morphological and cyclin D1 or t (11; 14).
  2. Men and women, 18-75 years of age.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  4. Measurable disease by computed tomography/magnetic resonance imaging (CT/MRI).
  5. Received prior regimens for MCL.
  6. Documented failure to achieve any response, [stable disease (SD) or progressive disease during treatment] or documented progressive disease after response to the most recent treatment regimen.
  7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
  8. Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
  9. Females of childbearing potential must agree to use highly effective forms of birth control throughout the course of the study and at least up to 90 days after last dose of study drug. Highly effective forms of birth control include abstinence, hysterectomy, bilateral oophorectomy with no menstrual bleeding for 6 months, intrauterine contraception, hormonal methods such as contraceptive injection, oral contraceptive, etc. Males must have undergone sterilization-vasectomy, or utilize a barrier method while the female partner utilizes the effective forms of birth control noted above.
  10. Life expectancy of > 4 months.
  11. Able to provide written informed consent and can understand and comply with the requirements of the study.

Exclusion Criteria:

  1. Current or history of central nervous system (CNS) lymphoma.
  2. Prior exposure to a BTK inhibitor before enrollment.
  3. Prior corticosteroids with anti-neoplastic intent within 7 days.
  4. Major surgery within 4 weeks of screening.
  5. Toxicity must recover from prior chemotherapy.
  6. History of other active malignancies within 2 years of study entry.
  7. Currently clinically significant active cardiovascular disease.
  8. QTcF > 450 msecs or other significant ECG abnormalities.
  9. Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
  10. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction [PCR]).
  11. Pregnant or lactating women.
  12. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study at risk.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03206970
Other Study ID Numbers  ICMJE BGB-3111-206
CTR20160888 ( Registry Identifier: Center for drug evaluation, CFDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
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: Jun Zhu, PhD Lymphoma Department of Beijing University Cancer Hospital
PRS Account BeiGene
Verification Date September 2019

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