Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies. (ICK)

April 14, 2021 updated by: M. Labots, Amsterdam UMC, location VUmc

Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.

The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of eight drug cohorts. Biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VUMedical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced solid malignancy
  • minimum age 18 years
  • indication for palliative treatment
  • measurable disease with at least one lesion accessable for biopsy

Exclusion Criteria:

  • Cardiovascular conditions including congestive heartfailure NYHA class >2
  • recent myocardial infarction or uncontrolled coronary artery disease
  • cardiac arrhythmias requiring anti-arrhythmic therapy
  • uncontrolled hypertension
  • uncontrolled infections
  • serious non-healing wound, ulcer or bone fracture
  • pregnant or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
Drug: Sunitinib
50 mg once daily, oral use, 14 days
Drug: Sorafenib
400 mg, twice daily, oral use, 14 days
Drug: Erlotinib
150 mg once daily, oral use, 14 days
Drug: Everolimus
10 mg once daily, oral use, 14 days
Drug: Lapatinib
1250 mg once daily, oral use, 14 days
Drug: Dasatinib
100 mg once daily, oral use, 14 days
Drug: Pazopanib
800 mg once daily, oral use, 14 days
Drug: Vemurafenib
960 mg twice daily, oral use, 15-21 days
Procedure: tumor biopsy
Procedure: skin biopsy (optional)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment
Time Frame: 2 weeks
2 weeks
intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment
Time Frame: 2 weeks
2 weeks
To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue
Time Frame: 2 weeks
2 weeks
To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: H.M.W. Verheul, MD, PhD, VU medical center Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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