A Study Comparing BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)

Description

This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib in subjects with MYD88 Mutation Waldenström's Macroglobulinemia.

Study Start Date

January, 25 2017

Estimated Completion Date

June 2021

Interventions

  • Drug: BGB-3111
  • Drug: Ibrutinib

Study ID

BeiGene -- BGB-3111-302

Status

Recruiting

Trial ID

NCT03053440

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

167

Sponsor

BeiGene

Inclusion Criteria

  • Clinical and definitive histologic diagnosis of WM
  • Measurable disease, requiring treatment
  • Patients with no prior therapy for WM, must be considered inappropriate candidates for treatment with a standard chemoimmunotherapy regimen
  • Age ? 18 years old
  • (ECOG) performance status of 0-2
  • Adequate bone marrow function
  • Adequate renal and hepatic function
  • ECHO/MUGA demonstrating left ventricular ejection fraction (LVEF)? the lower limit of institutional normal
  • Subjects may be enrolled who relapse after autologous stem cell transplant if they are at least 3 months after transplant, and after allogeneic transplant if they are at least 6 months post transplant.
  • 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. Males must have undergone sterilization
  • vasectomy, or utilize a barrier method
  • Life expectancy of > 4 months

Exclusion Criteria

  • Prior exposure to a BTK inhibitor
  • Evidence of disease transformation at the time of study entry
  • Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy given with antineoplastic intent, targeted therapy, or radiation therapy within 3 weeks, or antibody-based therapy within 4 weeks of the start of study drug
  • Major surgery within 4 weeks of study treatment
  • Toxicity of ? Grade 2 from prior anticancer therapy
  • 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 with curative intent
  • Currently active, clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease within 6 months of screening
  • QTcF prolongation (defined as a QTcF > 450 msec)
  • Active, clinically significant Electrocardiogram (ECG) abnormalities
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
  • Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
  • Known human immunodeficiency virus (HIV), or active hepatitis B or hepatitis C
  • Pregnant or lactating women
  • Any life-threatening illness, medical condition, organ system dysfunction, need for profound anticoagulation, or bleeding disorder, which, in the investigator's opinion, could compromise the subject's safety
  • Any medications which are strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (51)

Study Location Distance Name Phone Email
Massachussetts General Hospital - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
Massachussetts General Hospital - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
Massachussetts General Hospital - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
Massachussetts General Hospital - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
Massachussetts General Hospital - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Jorge Castillo MD None None
Weill Cornell Medial College - New York, New York 187.1 miles John Allan MD None None
Weill Cornell Medial College - New York, New York 187.1 miles John Allan MD None None
Weill Cornell Medial College - New York, New York 187.1 miles John Allan MD None None
Weill Cornell Medial College - New York, New York 187.1 miles John Allan MD None None
Weill Cornell Medial College - New York, New York 187.1 miles John Allan MD None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles Ian Flinn MD None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles Ian Flinn MD None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles Ian Flinn MD None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles Ian Flinn MD None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles Ian Flinn MD None None
Colorado Blood Cancer Institute - Denver, Colorado 1,766.9 miles Jeffrey Matous MD None None
Colorado Blood Cancer Institute - Denver, Colorado 1,766.9 miles Jeffrey Matous MD None None
Colorado Blood Cancer Institute - Denver, Colorado 1,766.9 miles Jeffrey Matous MD None None
Colorado Blood Cancer Institute - Denver, Colorado 1,766.9 miles Jeffrey Matous MD None None
Colorado Blood Cancer Institute - Denver, Colorado 1,766.9 miles Jeffrey Matous MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Craig Reeder MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Craig Reeder MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Patrick Johnston MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Patrick Johnston MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Craig Reeder MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Craig Reeder MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Craig Reeder MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Patrick Johnston MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Patrick Johnston MD None None
Mayo Clinic - Phoenix, Arizona 2,280.6 miles Patrick Johnston MD None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles Edward Libby MD None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles Edward Libby MD None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles Edward Libby MD None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles Edward Libby MD None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles Edward Libby MD None None
Desert Hematology Oncology Medical Group Inc - Rancho Mirage, California 2,511.4 miles Luke Dreisbach None None
Desert Hematology Oncology Medical Group Inc - Rancho Mirage, California 2,511.4 miles Luke Dreisbach None None
Desert Hematology Oncology Medical Group Inc - Rancho Mirage, California 2,511.4 miles Luke Dreisbach None None
Desert Hematology Oncology Medical Group Inc - Rancho Mirage, California 2,511.4 miles Luke Dreisbach None None
Desert Hematology Oncology Medical Group Inc - Rancho Mirage, California 2,511.4 miles Luke Dreisbach None None
City Of Hope National Medical Center - Duarte, California 2,578.2 miles Tanya Siddiqi None None
University of California San Diego UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles Michael Choi MD None None
University of California San Diego UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles Michael Choi MD None None
University of California San Diego UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles Michael Choi MD None None
University of California San Diego UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles Michael Choi MD None None
University of California San Diego UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles Michael Choi MD None None

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