To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma

NCT ID: NCT04582539

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2024-08-15

Brief Summary

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.

Conditions

Myelodysplastic Syndromes; Multiple Myeloma; Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INCB000928

INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.

Group Type: EXPERIMENTAL

INCB000928

Intervention Type: DRUG

INCB000928 will be administered once daily.

Interventions

INCB000928

INCB000928 will be administered once daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

For MDS participants:

• Ineligible to receive or have not responded to available therapies for anemia such as ESAs or lenalidomide.
• Not requiring cytoreductive therapy other than hydroxyurea.
• BM and peripheral blood myeloblast count < 10%.
• Histologically confirmed diagnosis of the MDS, CMML and unclassifiable MDS/MPN overlap syndromes.

For MM participants:

• Histologically confirmed diagnosis of MM.
• After failure of available standard treatments such as alkylating agents, glucocorticoids, immunomodulatory drugs (lenalidomide,pomalidomide, or thalidomide), proteasome inhibitors (bortezomib or carfilzomib), and daratumumab.

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.
• Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
• Undergoing treatment with another investigational medication or having been treated with an investigational medication within 28 days before the first dose of study drug. -Undergoing treatment with ESAs, granulocyte colony-stimulating factor or granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any time within 28 days before the first dose of study drug.
• Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug or expected to receive such treatment during the study.
• History of clinically significant or uncontrolled cardiac disease.
• History or presence of an abnormal ECG that, in the investigator's opinion, is clinically Meaningful.
• Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
• Diagnosis of chronic liver disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekatarine Asatiani, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Stanford Cancer Center

Palo Alto, California, United States

University of Miami

Miami, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Tulane Comprehensive Cancer Center

New Orleans, Louisiana, United States

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, United States

University of Cincinnati

Cincinnati, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Md Anderson Cancer Center

Houston, Texas, United States

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

Nantes, , France

Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Institut Gustave Roussy

Villejuif, , France

L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

Bologna, , Italy

Azienda Ospedaliero-Universitaria Careggi (Aouc)

Florence, , Italy

Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

Pavia, , Italy

Irccs Istituto Clinico Humanitas

Rozzano, , Italy

Countries

United States; France; Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-002771-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 00928-105

Identifier Type: -

Identifier Source: org_study_id