Phase I Clinical and Pharmacokinetic Study of BMS-247550, a Novel Derivative of Epothilone B, in Solid Tumors

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Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors.

PURPOSE The purpose of this study was to determine the maximum tolerated dose, toxicity, and pharmacokinetics of BMS-247550 administered as a 1-h i.v. infusion every 3 weeks. EXPERIMENTAL DESIGN Patients with advanced solid malignancies were premedicated and treated with escalating doses of BMS-247550. Blood sampling was performed to characterize the pharmacodynamics and pharmacokinetics of B...

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Phase I clinical trial of BMS-247550, a derivative of epothilone B, using accelerated titration 2B design.

PURPOSE BMS-247550 is a semisynthetic derivative of epothilone B with mechanism of action analogous to paclitaxel. It has shown impressive antitumor activity in preclinical studies including in taxane-resistant models. We conducted a phase I trial, based on accelerated titration "2B" design, of BMS-247550 given as a 1-hour infusion every 3 weeks. EXPERIMENTAL DESIGN Seventeen patients (M:F, 1...

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Validation of the pharmacodynamics of BMS-247550, an analogue of epothilone B, during a phase I clinical study.

The primary aims of this study were to evaluate the timecourse and dose response of microtubule bundle formationin peripheral blood mononuclear cells (PBMCs) and to correlate these data with BMS-247550 pharmacokinetics. The data presented here were obtained from 17 patients enrolled in a Phase I trial who received five dose levels of BMS-247550 (7.4-59.2 mg/m(2)), given as a 1-h infusion once e...

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Clinical trials referral resource. Current clinical trials of epothilone B analog (BMS-247550).

BMS-247550 is a methyl, semi-synthetic analog of the natural product epothilone B. Provided to the National Cancer Institute (NCI) by Bristol-Myers Squibb, BMS-247550 was chosen for clinical development because it demonstrated antitumor activity in paclitaxel (Taxol)-sensitive, paclitaxel-insensitive, and paclitaxel-resistant human tumor models. The first NCI-sponsored clinical trial of BMS-247...

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ژورنال

عنوان ژورنال: Clinical Cancer Research

سال: 2004

ISSN: 1078-0432,1557-3265

DOI: 10.1158/1078-0432.ccr-0919-03