- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01636908
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
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
-
-
-
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
|
50 mg once daily, oral use, 14 days
400 mg, twice daily, oral use, 14 days
150 mg once daily, oral use, 14 days
10 mg once daily, oral use, 14 days
1250 mg once daily, oral use, 14 days
100 mg once daily, oral use, 14 days
800 mg once daily, oral use, 14 days
960 mg twice daily, oral use, 15-21 days
|
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
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
- Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Sorafenib
- Sunitinib
- Everolimus
- Dasatinib
- Lapatinib
- Vemurafenib
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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