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NCT04640025 · ClinicalTrials.gov registry record · Phase 2
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
A Phase 2 study of Myelofibrosis and Chronic Graft Versus Host Disease, sponsored by Incyte Corporation.
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 20
- Study locations
NCT04640025: Active Phase 2 study of Myelofibrosis and Chronic Graft Versus Host Disease, sponsored by Incyte Corporation.
NCT04640025 is a Phase 2 study of Myelofibrosis and Chronic Graft Versus Host Disease that is active but no longer recruiting, run by Incyte Corporation. The registered enrollment target is 18 participants, below the 196-participant average among 61 other Myelofibrosis trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04640025, a Phase 2 study of Myelofibrosis and Chronic Graft Versus Host Disease, is active but no longer recruiting, sponsored by Incyte Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Conditions Studied
Interventions
- DRUG itacitinib
Study Locations (20)
Other
- Ordensklinikum Linz Gmbh Elisabethinen - Linz
- Universitaire Ziekenhuis Leuven - Gasthuisberg - Leuven
- Universitatsklinikum Halle (Saale) - Halle
- University Medical Centre Hamburg-Eppendorf Centre of Oncology - Hamburg
- University Hospital Mannheim - Mannheim
- University Hospital of West Attica - Attikon - Chaïdári
- Hadassah Hebrew University Medical Center Ein Karem Hadassah - Jerusalem
- Azienda Policlinico Vittorio Emanuele - Catania
- Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti - Reggio Calabria
- Aou San Giovanni Di Dio E Ruggi - Salerno
- Hospital Universitario Virgen de Las Nieves - Granada
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- Temple University Department of Thoracic Medicine and Surgery - Philadelphia
California
- City of Hope National Medical Center - Duarte
Colorado
- Anschutz Cancer Pavilion-University of Colorado - Aurora
Indiana
- Parkview Cancer Institute - Fort Wayne
Ohio
- Cleveland Clinic - Cleveland
Tennessee
- Sarah Cannon Research Institute - Nashville
Texas
- Texas Oncology San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2026-06-22 |
| Phase | Phase 2 |
What the registry record for NCT04640025 still lists
NCT04640025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 196-participant average among 61 other Myelofibrosis trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 1 intervention - of which itacitinib is the first listed.
NCT04640025 names 20 study sites across 9 states, led by Other, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT04640025 about?
NCT04640025 is a clinical study titled "A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib". 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 ...
What is the current status of trial NCT04640025?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2021-03-10. Estimated completion is 2026-06-22.
What conditions does trial NCT04640025 study?
This clinical trial studies the following conditions: Myelofibrosis, Chronic Graft Versus Host Disease, Postlung Transplant (Bronchiolitis Obliterans).
What interventions are being tested in trial NCT04640025?
The interventions under investigation include: itacitinib (DRUG).
Who is sponsoring clinical trial NCT04640025?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04640025 being conducted?
This trial has 20 study locations across California, Colorado, Indiana, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelofibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04640025's enrollment target sits among peer trials
18 55th of 61 higher than 6 of 61 other Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelofibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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