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An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV
ClinicalTrials.gov Identifier:
NCT02213926
First received: August 5, 2014
Last updated: October 13, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

Condition Intervention Phase
Mantle Cell Lymphoma (MCL) Drug: ACP-196 (acalabrutinib) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Acerta Pharma BV:

Primary Outcome Measures:
  • Overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with previously treated MCL. [ 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 ]

Enrollment: 124
Study Start Date: September 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACP-196 (acalabrutinib) Regimen 1
ACP-196 (acalabrutinib) Regimen 1
Drug: ACP-196 (acalabrutinib)

  Eligibility

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

Inclusion criteria:

  • Men and women ≥ 18 years of age.
  • Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.
  • 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 ACP-196 (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 corrected QT interval (QTc) > 480 msec.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Breast feeding or pregnant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02213926

Locations
United States, New York
New York, New York, United States
United Kingdom
Plymouth, United Kingdom
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Susan E Light, MD Acerta Pharma
  More Information

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02213926     History of Changes
Other Study ID Numbers: ACE-LY-004
Study First Received: August 5, 2014
Last Updated: October 13, 2016

Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
Mantle Cell Lymphoma
MCL
ACP-196
Acalabrutinib
ACE-LY-004

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on June 26, 2017