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.

What was studied

This study modeled how the body handles bosutinib in children. Bosutinib is a drug for chronic myelogenous leukemia with the Philadelphia chromosome. The team used data from 26 children in an early dose-finding trial. They analyzed 235 blood samples. They also used a model built from adult data. This is called a population pharmacokinetic model.

What they found

The model described the children's data well. Absorption had a lag time of 0.467 h. Clearance was 74.9 L/h, scaled to 70 kg. This is higher than the adult value of 56.3 L/h. Simulations showed the chosen dose could reach the same drug level as in adults. They also showed the effect of higher clearance in children.

What it means for patients

The authors say this is the first pediatric model for bosutinib. They say it confirms higher clearance in children. They say it supports the dose picked in the early trial.

Why it is not certain yet

The study used a small set of data. It came from an early trial stage. It describes drug levels, not cancer response. It does not show if children do better. The model relied on adult data for some parameters.

Source

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.

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