Clinical trial · Interventional
To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma
A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma
NCT04582539CI-TRIAL-00096729LIMBERterminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic Business Decision
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB000928 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INCB000928
- description
- INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.
- interventionNames
- Drug: INCB000928
Primary outcomes (5)
- measure
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- timeFrame
- up to 950 days
- description
- An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
- measure
- Number of Participants With Any ≥Grade 3 TEAE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.