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

Stopped early · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndromes, Multiple Myeloma, Anemia

In brief

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.

Key facts

Study ID

NCT04582539

Run by

Incyte Corporation

People needed

22

Starts

2021-08-19

Expected to finish

2024-08-15

Last updated by the study team

2025-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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