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A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
Sponsor: Incyte Corporation
Summary
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.
Official title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2021-03-10
Completion Date
2026-06-22
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
itacitinib
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
Locations (21)
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
Providence Health
Vancouver, British Columbia, Canada
Universitatsklinikum Halle (Saale)
Halle, Germany
University Medical Centre Hamburg-Eppendorf Centre of Oncology
Hamburg, Germany
University Hospital Mannheim
Mannheim, Germany
University Hospital of West Attica - Attikon
Chaïdári, Greece
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem, Israel
Azienda Policlinico Vittorio Emanuele
Catania, Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
Reggio Calabria, Italy
Aou San Giovanni Di Dio E Ruggi
Salerno, Italy
Hospital Universitario Virgen de Las Nieves
Granada, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain