Safety Study of AKN-028 in Patients With Acute Myelogenous Leukemia

Summary

This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML). The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML.

Timeline

Start

2011-12

Primary completion

2016-03

Completion

2016-03

Outcome

Outcome not reported

Stopped: “During the study two patients have experienced serious liver events related to AKN-028. The risk-benefit balance was judged to be negative.”

Publications

• Eriksson A, Kalushkova A, Jarvius M, Hilhorst R, Rickardson L, Kultima HG, de Wijn R, Hovestad L, Fryknas M, Oberg F, Larsson R, Parrow V, Hoglund M. AKN-028 induces cell cycle arrest, downregulation of Myc associated genes and dose dependent reduction of tyrosine kinase activity in acute myeloid leukemia. Biochem Pharmacol. 2014 Jan 15;87(2):284-91. doi: 10.1016/j.bcp.2013.10.022. Epub 2013 Nov 4.

Drugs

Indications