Targeted therapy selection based on tumor tissue kinase activity profiles for patients with advanced solid malignancies, an exploratory study
Completed
- Conditions
- Advanced solid tumorsmetastasized or inoperable cancer10027476
- Registration Number
- NL-OMON34546
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 43
Inclusion Criteria
Advanced solid malignancy, minimum age 18 years, no standard therapeutic options available, life expectancy of at least 12 weeks, measurable disease with at least one lesion assessable for biopsy.
Exclusion Criteria
Cardiovascular conditions including congestive heartfailure NYHA class >2, recent myocardial infarction or uncontrolled coronary artery disease, uncontrolled hypertension; uncontrolled infections; anticancer treatment during study or within 4 weeks of start of study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to determine the clinical benefit rate (CBR) of this<br /><br>therapy selection approach, defined by the number of patients demonstrating<br /><br>either a complete or partial response or stable disease after 12 weeks of<br /><br>treatment. Available phase I data of several registered tyrosine kinase<br /><br>inhibitors have shown CBR*s of approximately 10% in patients with advanced<br /><br>solid malignancies excluding renal cell carcinoma, hepatocellular carcinoma and<br /><br>GIST. Based on these data, we expect to increase CBR by ex vivo analysis and<br /><br>therapy selection to 25%.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To compare progression free survival (PFS) using a kinase inhibitor<br /><br>treatment regimen selected by kinase profiling with the PFS of the most recent<br /><br>treatment regimen on which the patient progressed (i.e., patients are their own<br /><br>controls).<br /><br>2. To determine the relation of Comparative Genomic Hybridization<br /><br>(CGH)-profiles with response to kinase inhibitors.<br /><br>3. To determine the relation of serum and tissue kinome proteomic and activity<br /><br>profiles with response to kinase inhibitors and survival.<br /><br>4. To correlate the frequency and phenotype of immunoregulatory cells in blood<br /><br>and tumor tissue with response to kinase inhibitors.<br /><br>5. To correlate individual pharmacodynamics with response to kinase inhibitors.</p><br>