Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Leukemia
Enrollment Eligibility
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.