This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol". Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
City of Hope National Medical Center
Duarte, California, United States
Anschutz Cancer Pavilion-University of Colorado
Aurora, Colorado, United States
Parkview Cancer Institute
Fort Wayne, Indiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Department of Thoracic Medicine and Surgery
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology San Antonio
San Antonio, Texas, United States
Ordensklinikum Linz Gmbh Elisabethinen
Linz, Austria
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, Belgium
...and 11 more locations
Treatment Emergent Adverse Events (TEAE's)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: 3 years
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