To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma
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.
Stanford is currently accepting patients for this trial.
Intervention(s):
- drug: INCB000928
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Joanna Denise De Vore
denised@stanford.edu
I'm interested
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.