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Influence of Exceptional Patient Characteristics on Everolimus Exposure

NCT01948960 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-12-07

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

everolimus dose escalation

patients with an AUC below mean will have dose escalation of everolimus based on their AUC

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Carla van Herpen, MD, PhD · Radboud university medical center, department of medical oncology

  • Nielka van Erp, PharmD, PhD · Radboud university medical center, department of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2018-01-15
Completion
2018-01-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01948960 on ClinicalTrials.gov