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 (50–1200 mg) was administered as a continuous 7-day in...

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Bibliographic Details
Published in:Leukemia research 2011-10, Vol.35 (10), p.1384-1389
Main Authors: Tsuboi, Kosuke, Yokozawa, Toshiya, Sakura, Toru, Watanabe, Takashi, Fujisawa, Shin, Yamauchi, Takahiro, Uike, Naokuni, Ando, Kiyoshi, Kihara, Rika, Tobinai, Kensei, Asou, Hiroya, Hotta, Tomomitsu, Miyawaki, Shuichi
Format: Article
Language:English
Subjects:
Acute myeloid leukemia
Adult
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - pharmacokinetics
Asian Continental Ancestry Group
Aurora B kinase inhibitor
aurora B protein
Aurora Kinase B
Aurora Kinases
AZD1152
Barasertib
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug-Related Side Effects and Adverse Reactions
Efficacy
Enzyme Inhibitors - administration & dosage
Enzyme Inhibitors - adverse effects
Enzyme Inhibitors - pharmacokinetics
Female
Hematology, Oncology and Palliative Medicine
Humans
Intravenous administration
Leukemia, Myeloid, Acute - drug therapy
Leukemia, Myeloid, Acute - pathology
Leukocyte Count
Male
Middle Aged
Neutropenia
Neutropenia - pathology
Organophosphates - administration & dosage
Organophosphates - adverse effects
Organophosphates - pharmacokinetics
Pharmacokinetics
Phase I
Protein-Serine-Threonine Kinases - antagonists & inhibitors
Protein-Serine-Threonine Kinases - metabolism
Quinazolines - administration & dosage
Quinazolines - adverse effects
Quinazolines - pharmacokinetics
Safety
Toxicity
Treatment Outcome
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Summary: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 (50–1200 mg) was administered as a continuous 7-day intravenous infusion every 21 days. No dose-limiting toxicities were reported and barasertib 1200 mg 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.
ISSN:0145-2126
1873-5835
DOI:10.1016/j.leukres.2011.04.008