Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors.

Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors. Research Abstract Details 

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Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors. Abstract Text:

Toshio Shimizu,Noboru Yamamoto,Yasuhide Yamada,Yasuhito Fujisaka,Kazuhiko Yamada,Yutaka Fujiwara,Kyoko Takayama,Takuto Tokudome,Judith Klimovsky,Tomohide Tamura,

BACKGROUND: Ixabepilone (BMS-247550) is the first in a new class of anti-neoplastic agents, the epothilone analogs, and is a highly active non-taxane anti-microtubule agent. This phase I study aimed to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), safety profile, pharmacokinetics, and antitumor activity of ixabepilone in Japanese patients. PATIENTS AND METHODS: Patients with solid tumors previously treated with up to four chemotherapy regimens received a 3-h intravenous infusion of ixabepilone every 3 weeks. RESULTS: Fourteen patients received 43 cycles (median 3, range 1-8). The most common adverse events were neutropenia, mild-to-moderate fatigue, anemia, and peripheral neuropathy. DLTs occurred in one patient receiving 40 mg/m(2) (grade 4 neutropenia for 9 days) and in two patients receiving 50 mg/m(2) (grade 3 mucositis, ileus and febrile neutropenia; grade 4 neutropenia for 10 days). One paclitaxel- and docetaxel-pretreated patient with non-small cell lung cancer achieved a partial response lasting for 3 months; six additional patients (43%) achieved disease stabilization with tumor shrinkage of 3-35%. The plasma concentration-time profiles of ixabepilone during cycle 1 were similar across all doses evaluated. CONCLUSIONS: The MTD of ixabepilone is 50 mg/m(2) given over 3 h every 3 weeks. The recommended phase II dose is 40 mg/m(2), which is well tolerated and active. Data from Japanese patients are consistent with published phase I data from non-Japanese patients.

Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors. Publishing Authors By Initials

T Shimizu,N Yamamoto,Y Yamada,Y Fujisaka,K Yamada,Y Fujiwara,K Takayama,T Tokudome,J Klimovsky,T Tamura,

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Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Cancer chemotherapy and pharmacology

VOLUME: 61

Page Numbers: 751-8

Journal Abbreviation: Cancer Chemother. Pharmacol.

ISSN: 0344-5704

DAY: 27

MONTH: 06

YEAR: 2007

Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors. Information

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LANGUAGE: eng

NlmUniqueID: 7806519

Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors. Keywords Mesh Terms:

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Grant and Affiliation Information for Phase I clinical and pharmacokinetic study of 3-weekly, 3-h infusion of ixabepilone (BMS-247550), an epothilone B analog, in Japanese patients with refractory solid tumors.

AFFILIATION: Division of Internal Medicine, National Cancer Center Hospital, Chuo-ku, Tokyo, 104-0045, Japan, tshimizu@nara.med.kindai.ac.jp.

Country: Germany

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MEDLINETA: Cancer Chemother Pharmacol

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