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Tumor Kinase Inhibitor Concentrations Measured by PET

NCT02111889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-04-07

No results posted yet for this study

Summary

The investigators hypothesize that response to kinase inhibitors is dependent on achieving pharmacological active drug levels in tumor tissue and that quantitative PET imaging can predict kinase inhibitors tumor concentrations. The ultimate aim is to develop a quantitative PET based imaging tool to differentiate between patients who will respond to therapy with kinase inhibitors.

The main objective of this study is to determine whether tumor concentrations of kinase inhibitors at pharmacological active doses can be predicted from PET studies using tracer amounts (microdosing) of corresponding radiolabeled kinase inhibitors. This objective includes the development and validation of pharmacokinetic models for radiolabeled kinase inhibitors as well as validation of the microdosing concept for kinase inhibitors.

Conditions

  • Disseminated Malignant Neoplasm

Interventions

OTHER

[11C] kinase inhibitor PET [15O]water PET and tumor biopsies.

\[11C\] kinase inhibitor PET (i.e. sorafenib and erlotinib in this study, with the aim to investigate others in future studies) and \[15O\]water PET will be performed before and after 2 weeks of treatment. Tumor biopsies will be performed before and after 2 weeks of therapy.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • H. M. Verheul, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-12-31
Completion
2017-02-28

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 NCT02111889 on ClinicalTrials.gov