Overview

This trial is active, not recruiting.

Condition mantle cell lymphoma (mcl)
Treatment acp-196 (acalabrutinib)
Phase phase 2
Target BTK
Sponsor Acerta Pharma BV
Start date September 2014
End date March 2017
Trial size 124 participants
Trial identifier NCT02213926, ACE-LY-004

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ACP-196 (acalabrutinib) Regimen 1
acp-196 (acalabrutinib)

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.
Location data was received from the National Cancer Institute and was last updated in October 2016.