Anemia, Myelofibrosis(MF), Polycythemia Vera (PV)

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

Incyte Study ID:

INCB 00928-104

CT.gov ID:

NCT04455841

Eudra ID:

N/A

Sponsor:

Incyte Corporation

Collaborator:

N/A

Study Contact Information:

1.855.463.3463 or [email protected]

Recruitment Complete

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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)

Anemia

Myelofibrosis(MF)

Polycythemia Vera (PV)

PRODUCT

Drug: INCB000928

Drug: ruxolitinib

COLLABORATORS

N/A

DATE

Mar 2021 - Nov 2025

TYPE

Interventional

PHASE

Phase 1/Phase 2

SEX

Female & Male

AGE

18+ years

ACCEPTS HEALTHY VOLUNTEERS

Key Inclusion and Exclusion Criteria

Inclusion Criteria

Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:
a. Anemia: An Hgb value < 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (Note: RBC transfusion must be at least 2 weeks before the Hgb measurement during screening).

Exclusion Criteria

Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for TGB only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.

Clinical Study Locations

Location

Status

Location

WASHINGTON UNIVERSITY SCHOOL OF MEDICINE

SAINT LOUIS, MO, US, 63110

Status

Recruiting

Location

MD ANDERSON CANCER CENTER

HOUSTON, TX, US, 77030

Status

Recruiting

Location

CITY OF HOPE NATIONAL MEDICAL CENTER

DUARTE, CA, US, 91010

Status

Recruiting

Location

VANDERBILT UNIVERSITY MEDICAL CENTER

NASHVILLE, TN, US, 37232

Status

Recruiting

Location

STANFORD CANCER CENTER

PALO ALTO, CA, US, 94304

Status

Recruiting

Location

WEILL CORNELL MEDICAL CENTERS

NEW YORK, NY, US, 10065

Status

Recruiting

Protocol Summary

Incyte Study ID:

INCB 00928-104

Primary Purpose:

Treatment

Allocation:

Non-randomized

Study Design:

Sequential Assignment

Masking:

None (Open Label)

Interventions:

Drug

Enrollment:

Primary Outcome

Open