Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
ICK
Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
1 other identifier
interventional
43
1 country
1
Brief Summary
The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Aug 2011
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 5, 2012
CompletedFirst Posted
Study publicly available on registry
July 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 15, 2021
April 1, 2021
6.4 years
July 5, 2012
April 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment
2 weeks
Secondary Outcomes (4)
kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment
2 weeks
intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment
2 weeks
To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue
2 weeks
To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue
2 weeks
Study Arms (1)
Kinase inhibitor
EXPERIMENTALPatients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
Interventions
Eligibility Criteria
You may qualify if:
- Advanced solid malignancy
- minimum age 18 years
- indication for palliative treatment
- measurable disease with at least one lesion accessable for biopsy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VUMedical Center
Amsterdam, 1081 HV, Netherlands
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
H.M.W. Verheul, MD, PhD
VU Medical Center Amsterdam
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncologist
Study Record Dates
First Submitted
July 5, 2012
First Posted
July 10, 2012
Study Start
August 1, 2011
Primary Completion
January 1, 2018
Study Completion
December 1, 2019
Last Updated
April 15, 2021
Record last verified: 2021-04