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

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    80
  • sponsor
    Incyte Corporation
Updated on 2 September 2021
anemia
myelodysplastic syndromes
multiple myeloma
hydroxyurea
lenalidomide
bortezomib
carfilzomib
chronic myelomonocytic leukaemia

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.

Details
Condition Bone marrow disorder, Multiple Myeloma, Blood disorder, Preleukemia, Anemia, Lymphoproliferative Disorder, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), Anemia; Non-Hodgkin’s Lymphoma, Hematological Disorders, Lymphoproliferative disorders, myelodysplastic syndromes, anaemia, multiple myeloma (mm), myelodysplastic syndrome (mds)
Treatment INCB000928
Clinical Study IdentifierNCT04582539
SponsorIncyte Corporation
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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
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