Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
18 Years
N/A
Both
Cancer, Advanced Solid Tumors
Trial Information
Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment
Outcome Time Frame:
2 weeks
Safety Issue:
No
Principal Investigator
H.M.W. Verheul, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
VU Medical Center Amsterdam
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
2011/128
NCT ID:
NCT01636908
Start Date:
August 2011
Completion Date:
Related Keywords:
- Cancer
- Advanced Solid Tumors
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