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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 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.

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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.

Conditions Studied

Anemia Post-Essential Thrombocythemia Myelofibrosis Post-Polycythemia Vera Myelofibrosis

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

FieldValue
Enrollment Target 84 participants
Start Date 2021-03-19
Est. Completion 2027-11-26
Phase Phase 1

Sponsor

Incyte Corporation

239 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04455841

The ClinicalTrials.gov registry entry for NCT04455841 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (80% lower). The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.