A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
- Conditions
- MyelofibrosisPostlung Transplant (Bronchiolitis Obliterans)Chronic Graft Versus Host Disease
- Interventions
- Registration Number
- NCT04640025
- Lead Sponsor
- Incyte Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).
- 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.
- Able to access itacitinib therapy commercially.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description itacitinib 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 Measures
Name Time Method Treatment Emergent Adverse Events (TEAE's) 3 years Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- 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
Scroll for more (11 remaining)City of Hope National Medical Center🇺🇸Duarte, California, United States