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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02159872 | Omacetaxine in Patients With Intermediate-1 and Higher Risk Myelodysplastic Syndrome (MDS) Post Hypomethylating Agent (HMA) Failure | PHASE2 | COMPLETED | 48 | — | — | May 18, 2015 | Apr 14, 2020 | Jun 9, 2021 | 1 | United States |
Overall survival defined as the time from treatment start to the time of death. Overall survival continuously monitored using the Bayesian method.
Response is Complete Response (CR) + Partial Response (PR) + Hematologic Improvement (HI). CR is the normalization of the peripheral blood and bone marrow with \</= 5% bone marrow blasts, a peripheral blood granulocyte count \>/= (1.0x10\^9/L, and a platelet count \>/= 100x10\^9/L). PR is the same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. HI meets all of the criteria for CR except for platelet recovery to \>/=100x10\^9L.
| Arm | Type | Description |
|---|---|---|
| Omacetaxine | EXPERIMENTAL | Omacetaxine 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle. Participant may continue taking the study drug for up to 24 cycles of treatment. |
| Name | Type | Description |
|---|---|---|
| Omacetaxine | DRUG | 1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle. |
Inclusion Criteria: 1. Age \>/= 18 years 2. Diagnosis of MDS confirmed within 10 weeks prior to study entry according to WHO criteria. Patients are either not eligible for or choose not to proceed with a stem cell transplant. 3. MDS classified as follows: RAEB-1 (5%-9% BM blasts); RAEB-2 (10%-19% B...