Population Pharmacokinetics of Bosutinib in Children with Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia Based on a Phase I Dose-Finding Trial (ITCC-054/COG AAML1921) and Pediatric Recommended Phase II Dosage Evaluation.
Clin PharmacokinetJul 27, 2026 (epub)
Jen-Hao Wu, Francisco Bautista, Erica Brivio et al.
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In 30 seconds
This study investigated the population pharmacokinetics of bosutinib in 26 pediatric patients with Philadelphia chromosome-positive chronic myelogenous leukemia, utilizing data from a Phase I dose-finding trial. The findings revealed a typical clearance of 74.9 L/h, which is higher than the adult value of 56.3 L/h, supporting the recommended phase II dosage for children.
Key findings
- Bosutinib pediatric pharmacokinetics were characterized by a two-compartment model with first-order absorption.
- The typical clearance in children was 74.9 L/h, exceeding the adult clearance of 56.3 L/h.
- Model-based simulations confirmed that the recommended phase II dose achieves target exposure levels seen in adults.
Why it matters
Understanding the pharmacokinetics of bosutinib in children is crucial for optimizing treatment regimens in pediatric patients with chronic myelogenous leukemia, ensuring effective dosing and minimizing toxicity.