Spots Global Cancer Trial Database for Influence of Exceptional Patient Characteristics on Everolimus Exposure
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Trial Identification
Brief Title: Influence of Exceptional Patient Characteristics on Everolimus Exposure
Official Title: Influence of Exceptional Patient Characteristics on Everolimus Exposure
Study ID: NCT01948960
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Maasziekenhuis Pantein, Boxmeer, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
St. Antonius Ziekenhuis, Nieuwegein, , Netherlands
Radboud university medical center, Nijmegen, , Netherlands
Bernhoven Ziekenhuis, Uden, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Contact Details
Name: Carla van Herpen, MD, PhD
Affiliation: Radboud university medical center, department of medical oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Nielka van Erp, PharmD, PhD
Affiliation: Radboud university medical center, department of Pharmacy
Role: PRINCIPAL_INVESTIGATOR
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