drugset / Trial / NCT01948960

Influence of Exceptional Patient Characteristics on Everolimus Exposure

NCT01948960

RandomizedParallel-groupOpen-labelDiagnostic

Summary

A study to determine whether everolimus pharmacokinetics in elderly and obese patients is different compared to control patients. Furthermore the investigators will investigate the relation between metabolic response assessed with \[18F\] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus exposure and clinical benefit. The investigators will explore whether dose escalation in patients who are hypothetically underexposed will result in an increase in metabolic response.

Timeline

Start
2013-08
Primary completion
2018-01-15
Completion
2018-01-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Everolimus Small molecule

Indications