Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT04279847
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • ET (Essential Thrombocythemia)
  • Myelodysplastic Syndrome
  • Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome
  • Myelofibrosis
  • Myeloproliferative Neoplasm
  • Relapsed or Refractory Primary Myelofibrosis
  • Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)

Eligibility Criteria

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

Interventions

  • INCB057643 — DRUG
    INCB057643 dose escalation and dose expansion.
  • Ruxolitinib — DRUG
    Ruxolitinib will be administered twice a day using the dose described for each Cohort in the protocol for Part 2.

Study Details

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis (MF) and other myeloid neoplasms.

Key Dates

Start date
Feb 23, 2021
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
140 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 : INCB057643 Monotherapy
    INCB057643 dose escalation and dose expansion
  • Experimental: Part 2 : INCB057643 Combination with Ruxolitinib
    Combination arm in dose escalation and dose expansion

Primary Outcome Measure

Number of treatment-emergent adverse events [ Time Frame: Up to approximately 9 months ]

Locations (19)

FacilityCityStateZIPSite coordinators
University of Alabama At BirminghamBirminghamAlabama35294-
University of Colorado Cancer CenterAuroraColorado80045-
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Emory University-Winship Cancer InstituteAtlantaGeorgia30322-
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of NjNew BrunswickNew Jersey08901-
Nyu Langone Health - Long Island HospitalMineolaNew York11501-
Nyu Langone Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-
Weill Medical College of Cornell UniversityNew YorkNew York10021-
University of North Carolina At Chapel HillChapel HillNorth Carolina27514-
University of Cincinnati Cancer InstituteCincinnatiOhio45267-
Ohio State UniversityColumbusOhio43210-
Oregon Health and Science UniversityPortlandOregon97239-
Texas Oncology-Baylor Sammons Cancer CenterDallasTexas75246-
Md Anderson Cancer CenterHoustonTexas77030-
Oncology ConsultantsHoustonTexas77030-
Huntsman Cancer Institute At University of UtahSalt Lake CityUtah84112-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Birmingham, AL

By research site
University of Alabama At Birmingham· Birmingham, ALUniversity of Colorado Cancer Center· Aurora, COUniversity of Miami Sylvester Comprehensive Cancer Center· Miami, FLEmory University-Winship Cancer Institute· Atlanta, GAUniversity of Iowa Hospital and Clinics· Iowa City, IAWashington University School of Medicine· St Louis, MO

Related Studies