INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

Part of paid clinical trials in Duarte, California.

Sponsor
Incyte Corporation
Study ID
NCT04455841
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Anemia
  • Post-essential Thrombocythemia Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis

Eligibility Criteria

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

Interventions

  • INCB000928 — DRUG
    INCB000928 will be administered at protocol defined dose.
  • ruxolitinib — DRUG
    Ruxolitinib will be administered at protocol defined dose.

Study Details

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.

Key Dates

Start date
Mar 19, 2021
Status verified
May 2026
Primary completion
Apr 1, 2025
Completion
Nov 26, 2027

Study Design

Enrollment
84 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group A (TGA)
    INCB000928 will be administered once daily (QD).
  • Experimental: Treatment Group B (TGB)
    INCB000928 will be administered in combination with ruxolitinib.
  • Experimental: Treatment Group C (TGC)
    INCB000928 will be administered in combination with ruxolitinib.

Primary Outcome Measure

Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE) [ Time Frame: up to approximately 4 years ]

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
City of Hope Orange CountyIrvineCalifornia92618-
Usc Norris Comprehensive Cancer CenterLos AngelesCalifornia90089-
Stanford Cancer CenterPalo AltoCalifornia94304-
Prebys Cancer CenterSan DiegoCalifornia92103-
Emory University - Winship Cancer InstituteAtlantaGeorgia30322-
Emory University-Winship Cancer InstituteAtlantaGeorgia30322-
Start MidwestGrand RapidsMichigan49546-
Washington University School of MedicineSt LouisMissouri63110-
Weill Cornell Medical CentersNew YorkNew York10065-
Duke University Medical Center, Department of Hematologic Malignancies and Cellular TherapyDurhamNorth Carolina27705-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Md Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CACity of Hope Orange County· Irvine, CAUsc Norris Comprehensive Cancer Center· Los Angeles, CAStanford Cancer Center· Palo Alto, CAPrebys Cancer Center· San Diego, CAEmory University - Winship Cancer Institute· Atlanta, GA

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