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|Therapy Name||APR-246 + Azacitidine|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|APR-246||p53 activator APR-246|PRIMA-1MET|PRIMA-1 analogue APR-246|Eprenetapopt||p53 Activator 10||APR-246 is an analogue of PRIMA-1, which modifies the core domain of mutant p53, resulting in restoration of wild-type p53 conformation and reactivation of normal p53 function, leading to increased cell cycle arrest and tumor cell death (PMID: 20498645, PMID: 29670092).|
|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).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03745716||Phase III||APR-246 + Azacitidine Azacitidine||APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)||Active, not recruiting||USA||1|
|NCT03931291||Phase II||APR-246 + Azacitidine||APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant||Recruiting||USA||0|
|NCT03072043||Phase Ib/II||APR-246 + Azacitidine||Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms||Active, not recruiting||USA||0|