Myelofibrosis(MF), Myelodysplastic Syndromes (MDS)

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

Incyte Study ID:

INCB 57643-103

CT.gov ID:

NCT04279847

Eudra ID:

N/A

Sponsor:

Incyte Corporation

Collaborator:

N/A

Study Contact Information:

1.855.463.3463 or [email protected]

Recruiting

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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)

Myelofibrosis(MF)

Myelodysplastic Syndromes (MDS)

PRODUCT

Drug: INCB057643

Drug: Ruxolitinib

COLLABORATORS

N/A

DATE

Feb 2021 - Dec 2025

TYPE

Interventional

PHASE

Phase 1

SEX

Female & Male

AGE

18+ years

ACCEPTS HEALTHY VOLUNTEERS

Clinical Study Locations

Name

Status

Name

UNIVERSITY OF MIAMI SYLVESTER COMPREHENSIVE CANCER CENTER

MIAMI, FL, US, 33136

Status

Recruiting

Name

UNIVERSITY OF ALABAMA AT BIRMINGHAM

BIRMINGHAM, AL, US, 35294

Status

Recruiting

Name

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL

CHAPEL HILL, NC, US, 27514

Status

Recruiting

Name

EMORY UNIVERSITY-WINSHIP CANCER INSTITUTE

ATLANTA, GA, US, 30322

Status

Recruiting

Name

HELSINKI UNIVERSITY CENTRAL HOSPITAL

HELSINKI, Finland, 00029

Status

Completed

Name

AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI (AOUC)

FIRENZE, Italy, 50134

Status

Recruiting

Key Inclusion and Exclusion Criteria

Inclusion Criteria

Age 18 years and older at the time of signing the informed consent.
Part 1 Monotherapy: Participants with confirmed diagnosis of relapsed or refractory MF (primary, or post-PV and post-ET), MDS, MDS/MPN, or ET who have received at least 1 prior line of therapy; are either refractory, relapsed, or intolerant to the last therapy; and there is no available therapy that would provide clinical benefit in the opinion of the investigator.

Exclusion Criteria

Prior receipt of a BET inhibitor.
Receipt of anticancer medications or investigational drugs within the protocol-defined interval before the first dose of study treatment. For Part 2 JAKi-naive, prior use of a JAK inhibitor (including ruxolitinib) and no use of experimental drug therapy for MF or any other standard drug (except hydroxyurea) used for MF or another indication within 3 months of starting study drug. For participants with suboptimal response to ruxolitinib, ruxolitinib will continue at the participants' current ongoing doses, no ruxolitinib washout is needed.

Protocol Summary

Incyte Study ID:

INCB 57643-103

Primary Purpose:

Treatment

Allocation:

Non-randomized

Study Design:

Parallel Assignment

Masking:

None (Open Label)

Interventions:

Drug

Enrollment:

231

Primary Outcome

Open