drugset / Trial / NCT02018926
Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS
NaSingle-groupOpen-labelTreatment
Summary
Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.
Timeline
- Start
- 2013-12
- Primary completion
- 2015-09
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Mocetinostat | Small molecule | 70 mg | Oral |
| Subject | Mocetinostat | Small molecule | 90 mg | Oral |