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

NCT04279847 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-04-01

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

INCB057643

INCB057643 dose escalation and dose expansion.

DRUG

Ruxolitinib

Ruxolitinib will be administered twice a day using the dose described for each Cohort in the protocol for Part 2.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Finland
  • Italy
  • Japan
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04279847 on ClinicalTrials.gov