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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. | ||||||||||||
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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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