Population pharmacokinetics-pharmacodynamics of sunitinib in pediatric patients with solid tumors.

ABSTRACT:

Purpose

The safety profile of sunitinib in children, including the impact of sunitinib exposure on safety endpoints, was assessed using population pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PK-PD) models.

Methods

Data were from two clinical studies in 59 children with solid tumors (age range 2-21 years, 28 male/31 female, body weight range 16.2-100 kg, body surface are [BSA] range 0.7-2.1 m²). Analysis of covariates that affected PK and PD parameters was conducted using a nonlinear mixed-effects model. Safety and tolerability endpoints were absolute neutrophil count, hepatic transaminases, diastolic blood pressure, hemoglobin, lymphocyte count, platelet count, white blood cell count, hand-foot syndrome, fatigue, nausea, intracranial hemorrhage, and

SUBMITTER: Wang E 

PROVIDER: S-EPMC7417410 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature