Myelodysplastic Syndromes (MDS), Myeloma, Anemia

To assess the safety and tolerability of INCB000928 in participants with Myelodysplastic Syndromes or Multiple Myeloma

Incyte Study ID:

INCB 00928-105

CT.gov ID:

NCT04582539

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 in

participants with MDS or MM who are transfusion-dependent or present with symptomatic

anemia.

Clinical Study Summary

MEDICAL CONDITION(S)

Myelodysplastic Syndromes (MDS)

Myeloma

Anemia

PRODUCT

Drug: INCB000928

COLLABORATORS

N/A

DATE

Aug 2021 - Sep 2024

TYPE

Interventional

PHASE

Phase 1/Phase 2

SEX

Female & Male

AGE

18+ years

ACCEPTS HEALTHY VOLUNTEERS

Clinical Study Locations

Name

BARBARA ANN KARMANOS CANCER HOSPITAL

DETROIT, MI, US, 48201

Name

TULANE COMPREHENSIVE CANCER CENTER

NEW ORLEANS, LA, US, 70112

Name

UNIVERSITY OF CINCINNATI

CINCINNATI, OH, US, 45219

Name

CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES (CHU DE NANTES) - HOTEL-DIEU

NANTES, France, 44093

Name

MD ANDERSON CANCER CENTER

HOUSTON, TX, US, 77030

Name

VANDERBILT UNIVERSITY MEDICAL CENTER

NASHVILLE, TN, US, 37232

Key Inclusion and Exclusion Criteria

Inclusion Criteria

Agreement to avoid pregnancy or fathering children.
Participants who are transfusion-dependent or present with symptomatic anemia

Exclusion Criteria

Any prior allogeneic stem cell transplantation or a candidate for such transplantation.
Any major surgery within 28 days before the first dose of study drug.

Protocol Summary

Incyte Study ID:

INCB 00928-105

Primary Purpose:

Treatment

Allocation:

N/A

Study Design:

Sequential Assignment

Masking:

None (Open Label)

Interventions:

Drug

Enrollment:

Primary Outcome

Open