To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental INCB000928 |
INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Incyte Corporation