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• W2591134611 abstract "2053 Background: BMS-275183 is a novel oral taxane with promising activity against NSCLC and other tumor types. The effect of food on absorption of BMS-275183 is not known. In this study, the effect of food on the pharmacokinetics (PK) of BMS-275183 was assessed in patients with advanced solid tumors refractory to standard therapy. The inter-patient PK variability after a fixed dose was also compared to that after a dose based on body surface area. Methods: Thirty-two patients were randomized to receive weekly 200 mg doses of BMS-275183 on each of three occasions: after a fast of 10 hours, 30 minutes after a standard low-fat meal, or 30 minutes after a standard high-fat meal. Patients were subsequently treated at the 200 mg/m2 Phase II dose on a continuous, weekly schedule under fasted conditions. Blood samples for BMS-275183 PK were collected predose and over 72 hours from the start of dosing on Days 1, 8, 15, and 22. BMS-275183 plasma concentrations were measured using a validated LC/MS/MS assay. Determination of food effect was based on bio-equivalence criteria Cmax and AUC. Results: BMS-275183 PK data are summarized for the 24 patients fully evaluable for PK assessment in the following table. Analysis of provisional data showed diminished Cmax and delayed Tmax, but no effect on AUC of BMS-275183 when given with food compared to the fasted state. The inter-patient variability of BMS-275183 AUC after a 200 mg dose was 84% and that after a 200 mg/m2 dose was 66%. BMS-275183 was generally well tolerated. Conclusions: Food affected the Cmax, but not the AUC of BMS-275183 and could moderate Cmax-related toxicities. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb" @default.
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• W2591134611 date "2005-06-01" @default.
• W2591134611 modified "2023-10-18" @default.
• W2591134611 title "The effect of food on the pharmacokinetics of BMS-275183, a novel oral taxane, in patients with advanced solid malignancies" @default.
• W2591134611 doi "https://doi.org/10.1200/jco.2005.23.16_suppl.2053" @default.
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