A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
NCT ID: NCT04640025
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
18 participants
INTERVENTIONAL
2021-03-10
2026-06-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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itacitinib
Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.
itacitinib
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
Interventions
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itacitinib
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently tolerating treatment as defined by the parent Protocol.
* Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
* Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
* Willingness to avoid pregnancy or fathering children..
* Ability to comprehend and willingness to sign an ICF.
Exclusion Criteria
* Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
* Pregnant or breastfeeding women.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Lance Leopold, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Countries
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Related Links
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A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
Other Identifiers
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2022-501661-47-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-002134-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 39110-801
Identifier Type: -
Identifier Source: org_study_id
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