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

Overview

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.

SparkCures ID 1146
Trial Phase Phase 1/2
Enrollment 22 Patients
Treatments
  • INCB000928
Tags
  • ALK2 Inhibitor
Trial Sponsors
  • Incyte Corporation
NCT Identifier

NCT04582539

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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