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• W2168314897 abstract "The clinical pharmacokinetics and exposure‐toxicity relationship were determined for EC145, a conjugate of folic acid and the Vinca alkaloid desacetylvinblastine hydrazide (DAVLBH), in cancer patients. EC145 plasma concentration and toxicity data were obtained from a first‐in‐man phase I study and analyzed by nonlinear mixed effect modeling with NONMEM. EC145 concentration‐time profile after intravenous administration was well described by a 2‐compartment model with a first‐order elimination process from the central compartment. BSA was identified as a significant covariate on EC145 clearance, accounting for 14.6% of interindividual variation on EC145 clearance. Population estimates for the clearance, steady‐state volume of distribution, distribution, and elimination half‐lives were 56.1 L/h, 26.1 L, 6 minutes, and 26 minutes, respectively. Constipation and peripheral neuropathy were the most common and clinically relevant toxicities. The clearance and area under the concentration‐time curve (AUC) were significant predictors for the incidence of EC145‐induced constipation but not peripheral neuropathy. In conclusion, EC145 is rapidly distributed and eliminated in cancer patients. BSA is a statistically significant covariate on EC145 clearance, but its clinical relevance remains to be defined. EC145‐induced constipation occurs at a higher frequency in the patients with lower EC145 clearance, where the drug exposure tends to be higher." @default.
• W2168314897 created "2016-06-24" @default.
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• W2168314897 date "2009-12-01" @default.
• W2168314897 modified "2023-10-18" @default.
• W2168314897 title "Clinical Pharmacokinetics and Exposure-Toxicity Relationship of a Folate-<i>Vinca</i>Alkaloid Conjugate EC145 in Cancer Patients" @default.
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• W2168314897 doi "https://doi.org/10.1177/0091270009339740" @default.
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