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• W2105152393 abstract "Abstract Purpose: Vismodegib, an orally bioavailable small-molecule Smoothened inhibitor, is approved for treatment of advanced basal cell carcinoma (BCC). We conducted a pharmacokinetic study of vismodegib in patients with advanced solid tumors to explore the effects of food on drug exposure. Experimental Design: In part I, patients were randomized to fasting overnight (FO), a high fat meal (HF), or a low fat meal (LF) before a single dose of vismodegib 150 mg. Plasma concentrations of vismodegib were determined by a validated liquid chromatography-tandem mass spectrometry assay. Primary endpoints were Cmax and area under the curve (AUC0–168). In part II, patients randomized to FO or HF in part I took vismodegib 150 mg daily after fasting; those randomized to LF took it after a meal. Primary endpoints after two weeks were Cmax and AUC0–24. Results: Sixty (22 FO, 20 HF, 18 LF) and 52 (25 fasting, 27 fed) patients were evaluable for primary endpoints in parts I and II, respectively. Mean Cmax and AUC0–168 after a single dose were higher in HF than FO patients [ratios of geometric means (90% CI) = 1.75 (1.30, 2.34) and 1.74 (1.25, 2.42), respectively]. There were no significant differences in Cmax or AUC0–24 between fasting and fed groups after daily dosing. The frequencies of drug-related toxicities were similar in both groups. Conclusions: A HF meal increases plasma exposure to a single dose of vismodegib, but there are no pharmacokinetic or safety differences between fasting and fed groups at steady-state. Vismodegib may be taken with or without food for daily dosing. Clin Cancer Res; 19(11); 3059–67. ©2013 AACR." @default.
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• W2105152393 date "2013-05-30" @default.
• W2105152393 modified "2023-09-25" @default.
• W2105152393 title "Evaluation of Food Effect on Pharmacokinetics of Vismodegib in Advanced Solid Tumor Patients" @default.
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• W2105152393 doi "https://doi.org/10.1158/1078-0432.ccr-12-3829" @default.
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