Therapy Detail

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Therapy Name Decitabine + Pacritinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Decitabine Dacogen 5-aza-2-deoxycytidine DNMT inhibitor (Pan) 5 Dacogen (decitabine) is cytidine analog that incorporates into DNA and forms covalent bonds with DNA methyltransferases (DNMTs), resulting in decreased DNMT activity and hypomethylation, and potentially leading to reduced tumor growth (PMID: 28159832, PMID: 25130173). Dacogen (decitabine) is FDA approved for use in patients with myelodysplastic syndromes (FDA.gov).
Pacritinib Vonjo SB1518|SB-1518|SB 1518 FLT3 Inhibitor 66 JAK2 Inhibitor - ATP competitive 15 Vonjo (pacritinib) is an inhibitor of JAK2 and FLT3, with activity against JAK2 V617F and FLT3 ITD, which potentially increases tumor cell apoptosis, induces cell cycle arrest, and decreases tumor growth (PMID: 22829080, PMID: 21691275). Vonjo (pacritinib) is FDA approved for use in patients with primary or secondary myelofibrosis (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 acute myeloid leukemia predicted - sensitive Decitabine + Pacritinib Phase I Actionable In a Phase I trial, treatment with Vonjo (pacritinib) in combination with Dacogen (decitabine) resulted in morphologic leukemia free state in 1 patient and stable disease in 5 of 8 patients with acute myeloid leukemia harboring a FLT3-ITD mutation, and resulted in a median overall survival of 292 days and a response rate of 23.1% when combined with either the combination of Cytosar-U (cytarabine) and Cerubidine (daunorubicin) or Dacogen (decitabine) (PMID: 31102119; NCT02323607). 31102119

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02323607 Phase I Cytarabine + Daunorubicin + Pacritinib Decitabine + Pacritinib Pacritinib and Chemotherapy in Treating Patients With Acute Myeloid Leukemia and FLT3 Mutations Completed USA 0
NCT02564536 Phase I Decitabine + Pacritinib Pacritinib in Combination With Low Dose Decitabine in Intermediate-High Risk Myelofibrosis or Myeloproliferative Neoplasm (MPN)/Myelodysplastic Syndrome (MDS) Withdrawn 0
NCT02532010 Phase II Decitabine + Pacritinib Cytarabine + Pacritinib Pacritinib Combined With Decitabine or Cytarabine in Older Patients With AML Terminated USA 0


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