Therapy Detail
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| Therapy Name | Azacitidine + Glasdegib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Azacitidine | Vidaza | azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg | DNMT inhibitor (Pan) 5 | Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov). |
| Glasdegib | Daurismo | PF-04449913 | SMO Inhibitor 16 | Daurismo (glasdegib) inhibits Smoothened (SMO), resulting in decreased Hedgehog (Hh) pathway signalling, and potentially inhibiting Hh-mediated tumor growth (PMID: 24900436, PMID: 25388167). Daurismo (glasdegib) is FDA approved for use in combination with low-dose cytarabine in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FLT3 act mut | acute myeloid leukemia | predicted - sensitive | Azacitidine + Glasdegib | Case Reports/Case Series | Emerging | In a Phase Ib trial, the combination of Daurismo (glasdegib) and Vidaza (azacitidine) resulted in an improved overall survival in acute myeloid leukemia patients harboring FLT3 mutations compared to those with wild-type FLT3 (P=0.039) (PMID: 35488900; NCT02367456). | 35488900 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03416179 | Phase III | Cytarabine Cytarabine + Daunorubicin + Glasdegib Azacitidine + Glasdegib Azacitidine Cytarabine + Daunorubicin | A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019) | Completed | USA | SWE | ROU | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUT | AUS | 6 |
| NCT02367456 | Phase Ib/II | Azacitidine + Glasdegib | A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In 1st Line MDS, AML and CMML Patients | Completed | USA | GBR | FRA | DEU | CAN | BEL | 0 |
| NCT03226418 | Phase II | Cytarabine Decitabine + Venetoclax Azacitidine + Venetoclax CPX-351 Cytarabine + Idarubicin Azacitidine + Glasdegib Decitabine + Glasdegib | Cytarabine, Idarubicin, Liposome-encapsulated Daunorubicin-Cytarabine or Decitabine in Treating Older Patients With Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
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