Therapy Detail

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Therapy Name Crenolanib + Sorafenib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Crenolanib CP-868596|CP-868,596 FLT3 Inhibitor 66 PDGFR Inhibitor (Pan) 30 Crenolanib (CP-868596) is a type III receptor tyrosine kinase inhibitor of PDGFR-alpha/beta and FLT3, which results in inhibition of downstream signaling and prevents growth in tumor cells (PMID: 22745105, PMID: 24227820, PMID: 29137311, PMID: 31309543).
Sorafenib Nexavar BAY 43-9006 CSF1R Inhibitor 28 FLT3 Inhibitor 66 KIT Inhibitor 57 PDGFR-beta Inhibitor 14 RAF Inhibitor (Pan) 27 RET Inhibitor 52 VEGFR2 Inhibitor 37 Nexavar (sorafenib) is a multikinase inhibitor with activity against several kinases, including RAF kinases, VEGFR2, VEGFR3, PDGFR-beta, KIT, FLT3, RET, and CSF1R, potentially resulting in decreased tumor growth (PMID: 18445656, PMID: 15466206, PMID: 21517818). Nexavar (sorafenib) is FDA approved for metastatic differentiated thyroid carcinoma, hepatocellular carcinoma, and renal cell carcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 14 ins FLT3 D835A acute myeloid leukemia resistant Crenolanib + Sorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, FLT3 D835A was identified as a secondary resistance mutation in FLT3 ITD-positive acute myeloid leukemia cell line xenograft models that progressed on the combination of Crenolanib (CP-868596) and Nexavar (sorafenib) (PMID: 35344039). 35344039
FLT3 exon 14 ins acute myeloid leukemia sensitive Crenolanib + Sorafenib Clinical Study Actionable In a clinical study, combination Nexavar (sorafenib) and Crenolanib (CP-868596) resulted in 2 complete remissions, 1 complete remission with incomplete blood count recovery, and 1 partial response of 8 evaluable pediatric patients with relapsed or refractory FLT3 ITD-positive acute myeloid leukemia, and in preclinical studies, resulted in synergy in cell culture and improved leukemia response and survival in xenograft models compared to either agent alone (PMID: 35344039). 35344039
FLT3 exon 14 ins FLT3 N841Y acute myeloid leukemia resistant Crenolanib + Sorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, FLT3 N841Y was identified as a secondary resistance mutation in FLT3 ITD-positive acute myeloid leukemia cell line xenograft models that progressed on the combination of Crenolanib (CP-868596) and Nexavar (sorafenib) (PMID: 35344039). 35344039
FLT3 exon 14 ins FLT3 D835N acute myeloid leukemia resistant Crenolanib + Sorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, FLT3 D835N was identified as a secondary resistance mutation in FLT3 ITD-positive acute myeloid leukemia cell line xenograft models that progressed on the combination of Crenolanib (CP-868596) and Nexavar (sorafenib) (PMID: 35344039). 35344039
FLT3 exon 14 ins FLT3 N841K acute myeloid leukemia resistant Crenolanib + Sorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, FLT3 N841K was identified as a secondary resistance mutation in FLT3 ITD-positive acute myeloid leukemia cell line xenograft models that progressed on the combination of Crenolanib (CP-868596) and Nexavar (sorafenib) (PMID: 35344039). 35344039
FLT3 exon 14 ins FLT3 F691L acute myeloid leukemia resistant Crenolanib + Sorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, FLT3 F691L was identified as a secondary resistance mutation in FLT3 ITD-positive acute myeloid leukemia cell line xenograft models that progressed on the combination of Crenolanib (CP-868596) and Nexavar (sorafenib) (PMID: 35344039). 35344039
FLT3 exon 14 ins FLT3 D835Y acute myeloid leukemia resistant Crenolanib + Sorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, FLT3 D835Y was identified as a secondary resistance mutation in FLT3 ITD-positive acute myeloid leukemia cell line xenograft models that progressed on the combination of Crenolanib (CP-868596) and Nexavar (sorafenib) (PMID: 35344039). 35344039

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02270788 Phase I Cytarabine + Leucovorin + Methotrexate Crenolanib + Sorafenib Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies Completed USA 0


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