Pilot study on the determination of intratumoral concentrations of kinase inhibitors in patients with advanced solid malignancies
Recruiting
- Conditions
- alle vormen van gevorderde, dwz inoperabele of uitgezaaide, solide tumorenAdvanced solid tumorsmetastasized/inoperable cancer10027655
- Registration Number
- NL-OMON36159
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine intratumoral kinase inhibitor concentrations upon 2 weeks of<br /><br>treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine kinase inhibitor concentrations in plasma, serum and PBMC's upon 2<br /><br>weeks of treatment.<br /><br>To determine intra-dermal kinase inhibitor concentrations upon 2 weeks of<br /><br>treatment.<br /><br><br /><br>To determine per patient whether 2 weeks of treatment with kinase inhibitors<br /><br>induces significant change of (1) phosphoproteomic profiles in tumor tissue;<br /><br>(2) kinase activity in tumor tissue; (3) markers for antiangiogenic and<br /><br>antiproliferative activity in tumor tissue; (4) serum peptide profiles </p><br>