A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

Part of paid clinical trials in Duarte, California.

Sponsor
Incyte Corporation
Study ID
NCT04640025
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • itacitinib — DRUG
    Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.

Study Details

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.

Key Dates

Start date
Mar 10, 2021
Status verified
Dec 2025
Primary completion
Jun 22, 2026
Completion
Jun 22, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Treatment Emergent Adverse Events (TEAE's) [ Time Frame: 3 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia31010-
Anschutz Cancer Pavilion-University of ColoradoAuroraColorado80045-
Parkview Cancer InstituteFort WayneIndiana46845-
Cleveland ClinicClevelandOhio44195-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Temple University Department of Thoracic Medicine and SurgeryPhiladelphiaPennsylvania19140-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Texas Oncology San AntonioSan AntonioTexas78240-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAAnschutz Cancer Pavilion-University of Colorado· Aurora, COParkview Cancer Institute· Fort Wayne, INCleveland Clinic· Cleveland, OHHospital of the University of Pennsylvania· Philadelphia, PATemple University Department of Thoracic Medicine and Surgery· Philadelphia, PA

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