Population exposure-safety analysis of cediranib for Phase I and II studies in patients with cancer.

ABSTRACT:

Aims

A multistudy analysis of cediranib, a potent, selective inhibitor of all three vascular endothelial growth factor receptors (VEGFR-1, -2 and -3), was conducted to establish population exposure-safety models for the relationship of cediranib exposure to the safety endpoints, diastolic and systolic blood pressure (DBP and SBP) and diarrhoea in cancer patients. These models were applied to predict safety outcomes for different cediranib dose regimens.

Methods

Models for hypertension and diarrhoea were constructed based on data from 10 Phase I and three Phase II studies comprising 631 cancer patients following cediranib once-daily oral dosing. Daily DBP and SBP were simultaneously characterized using indirect response models for predicted cediranib concentration-time course

SUBMITTER: Al-Huniti N 

PROVIDER: S-EPMC5867133 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature