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Investigational New Drugs
Published in: Investigational New Drugs 6/2012

01-12-2012 | PHASE I STUDIES

First clinical pharmacokinetic dose-escalation study of sagopilone, a novel, fully synthetic epothilone, in Japanese patients with refractory solid tumors

Authors: Kazuhiro Araki, Koichi Kitagawa, Hirofumi Mukai, Toru Mukohara, Keiji Kodama, Yuichi Ando, Masaru Narabayashi, Hironobu Minami, Kiyomi Mera, Yasutsuna Sasaki

Published in: Investigational New Drugs | Issue 6/2012

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Summary

Purpose Sagopilone has recently been identified and preferentially used for the treatment of taxane-resistant cancer. The purpose of this dose-escalation study was to investigate the safety, tolerability, and pharmacokinetics (PK) of sagopilone in refractory solid tumors. Methods A total of 17 Japanese patients received sagopilone in this Phase I study. Sagopilone was given as a 30-min intravenous infusion once every 3 weeks (one course) with an initial dose of 12.4 mg/m2 up to 22.0 mg/m2 for a maximum of 6 courses. Results The maximum tolerated dose (MTD) was determined to be 16.5 mg/m2. The major dose-limiting toxicity (DLT) was peripheral sensory neuropathy. The PK data demonstrated that sagopilone did not accumulate after repeated administration. Two patients had stable disease (SD) over a period of 12 weeks. Conclusions Our study demonstrated clinically favorable safety, tolerability, and efficacy of sagopilone, which will help define the treatment of advanced tumors in more extensive clinical trials.
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Metadata
Title
First clinical pharmacokinetic dose-escalation study of sagopilone, a novel, fully synthetic epothilone, in Japanese patients with refractory solid tumors
Authors
Kazuhiro Araki
Koichi Kitagawa
Hirofumi Mukai
Toru Mukohara
Keiji Kodama
Yuichi Ando
Masaru Narabayashi
Hironobu Minami
Kiyomi Mera
Yasutsuna Sasaki
Publication date
01-12-2012
Publisher
Springer US
Published in
Investigational New Drugs / Issue 6/2012
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-011-9773-7

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