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An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia

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: NCT02180724
Recruitment Status : Active, not recruiting
First Posted : July 3, 2014
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Study Description
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Brief Summary:
This study is evaluating the safety and efficacy of acalabrutinib for the treatment of subjects with Waldenström Macroglobulinemia (WM)

Condition or disease Intervention/treatment Phase
Waldenström Macroglobulinemia (WM) Drug: Acalabrutinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia
Actual Study Start Date : July 2014
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : August 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Acalabrutinib Regimen 1
Acalabrutinib Regimen 1
 Drug: Acalabrutinib


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) of acalabrutinib in subjects with previously treated WM [ Time Frame: Participants will be followed every 28 days or until progression of disease or start of another anti-cancer treatment for at least 1 year ]

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

Inclusion Criteria:

  • Men and women ≥ 18 years of age
  • A confirmed diagnosis of WM, which requires treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria:

  • A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk.
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF < 40%
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Breast feeding or pregnant.
Contacts and Locations
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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): NCT02180724


Locations
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United States, District of Columbia
Washington, District of Columbia, United States
United States, New York
New York, New York, United States
United States, Texas
Houston, Texas, United States
Netherlands
Amsterdam, Netherlands
United Kingdom
Leicester, United Kingdom
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
More Information
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02180724     History of Changes
Other Study ID Numbers: ACE-WM-001
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
Waldenström Macroglobulinemia
 WM
Waldenström
Macroglobulinemia

Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases