ArticleCPT: pharmacometrics & systems pharmacology2022
Population pharmacokinetics for oral paclitaxel in patients with advanced/metastatic solid tumors.
Article in CPT: pharmacometrics & systems pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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4 citing papers in PubMed, 5 citations in OpenAlex.
- Model-Driven Optimization of Subcutaneous Polymer Prodrugs Achieves Cancer Remission in Mice.Advanced healthcare materials · 2026Article
- Nonlinear Mixed-Effects Modeling to Characterize the Pharmacokinetics of a Novel Mithramycin Analogue for Ewing Sarcoma in Mice.Research square · 2026Article
- Oral docetaxel plus encequidar - a phase 1 clinical trial.Cancer chemotherapy and pharmacology · 2024Article
- Population pharmacokinetics for oral paclitaxel in patients with advanced/metastatic solid tumors.CPT: pharmacometrics & systems pharmacology · 2022Article
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Authors and funding
15 authors at 10 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Oraxol consists of an oral dosage form of the chemotherapeutic agent paclitaxel administered with a novel P-glycoprotein inhibitor encequidar methanesulfonate monohydrate (formerly named HM30181A), which allows oral treatment of cancers that would otherwise be treated with intravenous paclitaxel. Here we describe the population pharmacokinetics (popPK) analyses for oral paclitaxel in patients with advanced/metastatic solid tumors to characterize pharmacokinetic (PK) profiles and quantify sources of PK variability. The best fit popPK model for oral paclitaxel, based on data from seven clinical studies (197 patients with advanced/metastatic solid tumors), involves a linear two-compartment structural model containing first-order absorption with a short lag time and first-order elimination as well as a log additive error. In this popPK model, lower population estimates of central volume for Asian patients versus Caucasian patients did not translate into clinical meaningful differences in oral paclitaxel exposure. Age, sex, body weight or surface area, mild hepatic impairment, and mild to moderate renal impairment had no clinically meaningful effects on the systemic exposure of oral paclitaxel. Simulations were performed on clinical therapeutic dose (oral paclitaxel 205 mg/m
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