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A Phase I study to assess the safety, pharmacokinetics and efficacy of barasertib (AZD1152), an Aurora B kinase inhibitor, in Japanese patients with advanced acute myeloid leukemia.

Abstract
Barasertib (AZD1152) is a highly potent and selective Aurora B kinase inhibitor. The safety, efficacy and pharmacokinetic (PK) profile of barasertib were investigated in Japanese patients with advanced acute myeloid leukemia. Barasertib (50-1200mg) was administered as a continuous 7-day intravenous infusion every 21 days. No dose-limiting toxicities were reported and barasertib 1200mg was chosen for further evaluation in Japanese patients. Neutropenia and febrile neutropenia were the most commonly reported adverse events. The PK profile was similar to Western patients. A promising overall hematologic response rate of 19% was achieved, which warrants further investigation in these patients.
AuthorsKosuke Tsuboi, Toshiya Yokozawa, Toru Sakura, Takashi Watanabe, Shin Fujisawa, Takahiro Yamauchi, Naokuni Uike, Kiyoshi Ando, Rika Kihara, Kensei Tobinai, Hiroya Asou, Tomomitsu Hotta, Shuichi Miyawaki
JournalLeukemia research (Leuk Res) Vol. 35 Issue 10 Pg. 1384-9 (Oct 2011) ISSN: 1873-5835 [Electronic] England
PMID21565405 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study)
CopyrightCopyright © 2011 Elsevier Ltd. All rights reserved.
Chemical References
  • 2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphate
  • Antineoplastic Agents
  • Enzyme Inhibitors
  • Organophosphates
  • Quinazolines
  • AURKB protein, human
  • Aurora Kinase B
  • Aurora Kinases
  • Protein Serine-Threonine Kinases
Topics
  • Adult
  • Antineoplastic Agents (administration & dosage, adverse effects, pharmacokinetics)
  • Asian People
  • Aurora Kinase B
  • Aurora Kinases
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug-Related Side Effects and Adverse Reactions
  • Enzyme Inhibitors (administration & dosage, adverse effects, pharmacokinetics)
  • Female
  • Humans
  • Leukemia, Myeloid, Acute (drug therapy, pathology)
  • Leukocyte Count
  • Male
  • Middle Aged
  • Neutropenia (pathology)
  • Organophosphates (administration & dosage, adverse effects, pharmacokinetics)
  • Protein Serine-Threonine Kinases (antagonists & inhibitors, metabolism)
  • Quinazolines (administration & dosage, adverse effects, pharmacokinetics)
  • Treatment Outcome

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