Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02018926 | Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS | PHASE1 | COMPLETED | 18 | — | — | Dec 1, 2013 | Sep 1, 2015 | Sep 14, 2017 | 10 | United States |
| Arm | Type | Description |
|---|---|---|
| Mocetinostat and azacitidine | EXPERIMENTAL | Drug: Mocetinostat (MGCD0103) Mocetinostat (a histone deacetylase \[HDAC\] inhibitor) 70 mg or 90 mg dose, oral capsules 3 times weekly beginning on day 5 for 10 doses in each 28 day cycle Drug: Azacitidine (Vidaza) Azacitidine (a hypomethylating agent \[HMA\]) 75 mg/m2 dose, by intravenous (IV) infusion or subcutaneous (SC) injection beginning on day 1 for 7 doses in each 28 day cycle |
| Name | Type | Description |
|---|---|---|
| Mocetinostat | DRUG | Mocetinostat (a histone deacetylase \[HDAC\] inhibitor) 70 mg or 90 mg dose, oral capsules 3 times weekly beginning on day 5, for 10 doses in each 28 day cycle |
| Azacitidine | DRUG | Azacitidine (a hypomethylating agent \[HMA\]) 75 mg/m2 dose, by intravenous (IV) infusion or subcutaneous (SC) injection beginning on day 1 for 7 doses in each 28 day cycle |
Inclusion Criteria: Diagnosis of intermediate- or high-risk (IPSS criteria) myelodysplastic syndrome. Cohort 1: Any prior treatment, enrollment complete. Cohort 2: Limited or no prior treatment for MDS. Prior treatment should not include hypomethylating agents such as azacitidine or decitabine, or...