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Ref Type Journal Article
PMID (32037935)
Authors Liva SG, Coss CC, Wang J, Blum W, Klisovic R, Bhatnagar B, Walsh K, Geyer S, Zhao Q, Garzon R, Marcucci G, Phelps MA, Walker AR
Title Phase I study of AR-42 and decitabine in acute myeloid leukemia.
Journal Leukemia & lymphoma
Vol 61
Issue 6
Date 2020 Jun
Abstract Text This phase I trial sought to determine a biologically safe and effective dose of AR-42, a novel histone deacetylase inhibitor, which would lead to a doubling of miR-29b prior to decitabine administration. Thirteen patients with previously untreated or relapsed/refractory AML were treated at 3 dose levels (DL): AR-42 20 mg qd on d1,3,5 in DL1, 40 mg qd on d1,3,5 in DL2 and 40 mg qd on d1,3,4,5 in DL3. Patients received decitabine 20 mg/m2 on d6-15 of each induction cycle and 20 mg/m2 on d6-10 of each maintenance cycle. One DLT of polymicrobial sepsis and multi-organ failure occurred at DL3. Two patients achieved a CRi and one patient achieved a CR for an ORR of 23.1%. The higher risk features of this patient population and the dosing schedule of AR-42 may have led to the observed clinical response and failure to meet the biologic endpoint.


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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown acute myeloid leukemia no benefit AR-42 + Decitabine Phase I Actionable In a Phase I trial, AR-42 and Dacogen (decitabine) combination treatment in patients with acute myeloid leukemia resulted in an overall response rate of 23.1% (3/13), including one patient with complete remission and two patients with complete remission with incomplete count recovery, but the trial did not meet its biological endpoint for safety and dosing (PMID: 32037935; NCT01798901). 32037935