Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azacytidine · 1 trial · 1 indication
Criteria for response per the International Working Group for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Complete Response (CR) was defined as \</= 5% blasts in the bone marrow (BM) with peripheral blood (PB) demonstrating greater thatn 1x10\^9/L platelets with no detectable extramedullary disease. CR with incomplete recovery of PB counts (CRi) is the above criteria but neutrophil or platelet counts less than the stated values. Partial Response (PR) required all of the hematologic values for a CR but with a reduction of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.
| Arm | Type | Description |
|---|---|---|
| Azacytidine + Sorafenib | EXPERIMENTAL | Azacitidine 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) daily for 7 days per 28 day cycle. Sorafenib administered orally at a dose of 400 mg twice daily every day continuously. |
| Name | Type | Description |
|---|---|---|
| Azacytidine | DRUG | 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle. |
| Sorafenib | DRUG | 400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle. |
Inclusion Criteria: 1. Patients with untreated AML (\> or equal to 20% blasts in bone marrow and/or peripheral blood) or high risk MDS (\> or equal to 10% blasts in bone marrow). A. Patients with AML and history of MDS who have received prior therapy with a hypomethylating agent (including azacytid...
Top 20 of 63 competitors
Azacytidine is being studied for the treatment of leukemia, specifically in combination with sorafenib as initial therapy for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MS) who have the FLT3-ITD mutation. It is an investigational small molecule in Phase 2 clinical development.
Azacytidine is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is currently in Phase 2 clinical development for the treatment of leukemia.
Azacytidine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, and the drug is not yet available as a standard treatment.
Azacytidine has been studied in one completed Phase 2 clinical trial, NCT02196857. This trial evaluated sorafenib plus 5-azacitidine as initial therapy for patients with acute myeloid leukemia and high-risk myelodysplastic syndrome with the FLT3-ITD mutation. The trial enrolled 16 participants in the United States.
Yes, Azacytidine is also known as 5-azacitidine. In clinical trial NCT02196857, the drug is referred to as 5-azacitidine, and it is being studied in combination with sorafenib for the treatment of leukemia.