drugset / Trial / NCT01948960
Influence of Exceptional Patient Characteristics on Everolimus Exposure
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Everolimus | Small molecule | — | — |