Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

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: NCT02112526
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).

Condition or disease Intervention/treatment Phase
Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL) Drug: Acalabrutinib Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase 1b Study of ACP 196 in Subjects With Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Actual Study Start Date : August 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: Acalabrutinib Drug: Acalabrutinib
Other Name: ACP-196




Primary Outcome Measures :
  1. The frequency (number and percentage) of treatment emergent adverse events (safety) [ Time Frame: First dose of study drug until 30 days after last dose of study drug ]
    Safety will be determined by assessing toxicity based upon Common Terminology Criteria for Adverse Events (CTCAE) v4


Secondary Outcome Measures :
  1. Area under the plasma concentration (AUC) [ Time Frame: 1 Cycle (28 days) ]
    To Characterize the Pharmacokinetic parameter AUC of acalabrutinib

  2. Maximum observed plasma concentration (Cmax) [ Time Frame: 1 Cycle (28 days) ]
    To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib

  3. Evaluate Pharmacodynamic (PD) effects [ Time Frame: 2 Cycles (1 cycle = 28 days) and at end of treatment, assessed up to Cycle 48 (1 cycle is 28 days) ]
    To evaluate the concentration pharmacodynamic effects of acalabrutinib

  4. Evaluate Activity of acalabrutinib as measured by Overall Response Rate (ORR) [ Time Frame: From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days) ]
    To evaluate the activity of acalabrutinib as measured by ORR



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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.
  • Pathologically confirmed de novo ABC DLBCL
  • Relapsed or refractory disease
  • Subjects must have ≥ 1 measurable disease sites

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 > 50%
  • 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

Information from the National Library of Medicine

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): NCT02112526


Locations
Layout table for location information
United States, California
Los Angeles, California, United States, 90095
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, New York
New York, New York, United States, 10021
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Texas
Houston, Texas, United States, 77303
United Kingdom
Leicester, United Kingdom
Plymouth, United Kingdom
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Layout table for investigator information
Study Director: Acerta Clinical Trials Acerta Pharma, LLC

Layout table for additonal information
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02112526     History of Changes
Other Study ID Numbers: ACE-LY-002
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

Keywords provided by Acerta Pharma BV:
de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
de Novo Activated B-cell (ABC)
de Novo Activated B-cell
ABC DLBCL
DLBCL
Lymphoma
B-Cell
Immunoproliferative Disorders
Immune System Diseases
Bruton's tyrosine kinase

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin