Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-05 @ 12:38 AM
Study NCT ID:
NCT01948960
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2013-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Exceptional Patient Characteristics on Everolimus Exposure
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
Official Title:
Influence of Exceptional Patient Characteristics on Everolimus Exposure
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INPRES
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: