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Therapy Name	Dubermatinib
Synonyms
Therapy Description	Dubermatinib (TP-0903) is a selective Axl inhibitor that inhibits tumor cell survival (PMID: 22247788, PMID: 32460059, PMID: 31992541).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Dubermatinib		TP-0903	AXL Inhibitor 30	Dubermatinib (TP-0903) is a selective Axl inhibitor that inhibits tumor cell survival (PMID: 22247788, PMID: 32460059, PMID: 31992541).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FLT3 exon 14 ins	acute myeloid leukemia	sensitive	Dubermatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Dubermatinib (TP-0903) treatment resulted in cell cycle arrest and apoptosis, induced differentiation, and inhibited growth of acute myeloid leukemia cell lines harboring a FLT3-ITD mutation in culture, and reduced tumor growth and increased survival in cell line xenograft models (PMID: 33268594).	33268594
FLT3 exon 14 ins FLT3 D835Y	acute myeloid leukemia	sensitive	Dubermatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Dubermatinib (TP-0903) treatment resulted in cell cycle arrest and apoptosis, induced differentiation, and inhibited growth of acute myeloid leukemia cells harboring a FLT3-ITD mutation and FLT3 D835Y in culture, and reduced tumor growth and increased survival in cell line xenograft models (PMID: 33268594).	33268594
FLT3 exon 14 ins FLT3 F691L	hematologic cancer	sensitive	Dubermatinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Dubermatinib (TP-0903) treatment decreased phosphorylation of Flt3 and Stat5 and inhibited growth of transformed cells expressing a FLT3-ITD mutation and FLT3 F691L in culture, and reduced peripheral blood tumor burden in cell line xenograft models (PMID: 33268594).	33268594
FLT3 D835H	hematologic cancer	sensitive	Dubermatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Dubermatinib (TP-0903) inhibited growth of transformed cells expressing FLT3 D835H in culture (PMID: 33268594).	33268594
FLT3 D835Y	hematologic cancer	sensitive	Dubermatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Dubermatinib (TP-0903) inhibited growth of transformed cells expressing FLT3 D835Y in culture (PMID: 33268594).	33268594
FLT3 exon 14 ins	hematologic cancer	sensitive	Dubermatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Dubermatinib (TP-0903) inhibited growth of transformed cells expressing a FLT3-ITD mutation in culture (PMID: 33268594).	33268594
FLT3 exon 14 ins FLT3 D835H	hematologic cancer	sensitive	Dubermatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Dubermatinib (TP-0903) inhibited growth of transformed cells expressing a FLT3-ITD mutation and FLT3 D835H in culture (PMID: 33268594).	33268594
FLT3 exon 14 ins FLT3 D835Y	hematologic cancer	sensitive	Dubermatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Dubermatinib (TP-0903) inhibited growth of transformed cells expressing a FLT3-ITD mutation and FLT3 D835Y in culture (PMID: 33268594).	33268594
FLT3 exon 14 ins NRAS G12D	acute myeloid leukemia	predicted - sensitive	Dubermatinib	Preclinical - Cell culture	Actionable	In a preclinical study, Dubermatinib (TP-0903) inhibited growth of acute myeloid leukemia cells harboring a FLT3-ITD mutation and NRAS G12D in culture (PMID: 33268594).	33268594
FLT3 exon 14 ins IDH2 R140Q	acute myeloid leukemia	predicted - sensitive	Dubermatinib	Preclinical	Actionable	In a preclinical study, Dubermatinib (TP-0903) treatment inhibited growth and colony formation of cells isolated from a transgenic mouse model of acute myeloid leukemia harboring a FLT3-ITD mutation and IDH2 R140Q in culture, and increased survival in mouse models (PMID: 33268594).	33268594

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02729298	Phase I	Dubermatinib	First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors	Completed	USA	0
NCT04518345	Phase Ib/II	Dubermatinib Azacitidine + Dubermatinib	TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia	Completed	USA	0
NCT03572634	Phase Ib/II	Dubermatinib Dubermatinib + Ibrutinib	Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL	Terminated	USA	0

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