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NCT04455841 · ClinicalTrials.gov registry record · Phase 1
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
A Phase 1 study of Anemia and Post-Essential Thrombocythemia Myelofibrosis, sponsored by Incyte Corporation.
- Active
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT04455841: Active Phase 1 study of Anemia and Post-Essential Thrombocythemia Myelofibrosis, sponsored by Incyte Corporation.
NCT04455841 is a Phase 1 study of Anemia and Post-Essential Thrombocythemia Myelofibrosis that is active but no longer recruiting, run by Incyte Corporation. The registered enrollment target is 84 participants, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04455841, a Phase 1 study of Anemia and Post-Essential Thrombocythemia Myelofibrosis, is active but no longer recruiting, sponsored by Incyte Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug/treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of stud
Conditions Studied
Interventions
- DRUG INCB000928
- DRUG ruxolitinib
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- City of Hope Orange County - Irvine
- Usc Norris Comprehensive Cancer Center - Los Angeles
- Stanford Cancer Center - Palo Alto
- Prebys Cancer Center - San Diego
Other
- Centre Hospitalier D'Angers - Angers
- Institut Paoli Calmettes - Marseille
- Hospital Saint Louis - Paris
- Azienda Ospedaliera Papa Giovanni Xxiii - Bergamo
- S Orsolas University Hospital Seragnoli Institute of Hematology - Bologna
Georgia
- Emory University - Winship Cancer Institute - Atlanta
- Emory University-Winship Cancer Institute - Atlanta
Michigan
- Start Midwest - Grand Rapids
Missouri
- Washington University School of Medicine - St Louis
New York
- Weill Cornell Medical Centers - New York
North Carolina
- Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy - Durham
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2021-03-19 |
| Est. Completion | 2027-11-26 |
| Phase | Phase 1 |
What the registry record for NCT04455841 still lists
NCT04455841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which INCB000928 is the first listed.
NCT04455841 names 20 study sites across 11 states, led by California, Other, Georgia.
Frequently Asked Questions
What is clinical trial NCT04455841 about?
NCT04455841 is a clinical study titled "INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders". This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This stud...
What is the current status of trial NCT04455841?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2021-03-19. Estimated completion is 2027-11-26.
What conditions does trial NCT04455841 study?
This clinical trial studies the following conditions: Anemia, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis.
What interventions are being tested in trial NCT04455841?
The interventions under investigation include: INCB000928 (DRUG), ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04455841?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04455841 being conducted?
This trial has 20 study locations across California, Georgia, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04455841's enrollment target sits among peer trials
84 48th of 72 higher than 25 of 72 other Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anemia 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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