Incb 00928-105 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
Posted Date: Jul 13, 2021
- Investigator: Emily Curran
- Specialties: Cancer, Oncology
- Type of Study: Drug
The purpose of this study is 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. Efficacy will be determined by measuring the number of treatment-related adverse events.
Participants Must Agree To Avoid Pregnancy Or Fathering Children, Participants Must Be Transfusion-Dependent Or Present With Symptomatic Anemia, Must Be Ineligible To Receive Or Have Not Responded To Available Therapies For Anemia Such As Esas Or Lenalidomide, Must Have Bm And Peripheral Blood Myeloblast Count < 10%. Histologically Confirmed Diagnosis Of The Mds, Cmml And Unclassifiable Mds/Mpn Overlap Syndromes. Histologically Confirmed Diagnosis Of Mm. No Prior Allogeneic Stem Cell Transplantation Or A Candidate For Such Transplantation. No Major Surgery Within 28 Days Before The First Dose Of Study Drug. No 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. No History Of Clinically Significant Or Uncontrolled Cardiac Disease. No History Or Presence Of An Abnormal Ecg. No Presence Of Chronic Or Current Active Infectious Disease Requiring Systemic Antibiotic, Antifungal, Or Antiviral Treatment. No Diagnosis Of Chronic Liver Disease.
For More Information:
Uc Cancer Center