Targeted therapy with imatinib for treatment of poor prognosis mesenchymal-type resectable colon cancer: a proof-of-concept study in the preoperative window period.
Phase 2
Completed
- Conditions
- colon cancerlarge intestinal cancer10017991
- Registration Number
- NL-OMON47074
- Lead Sponsor
- Oncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 27
Inclusion Criteria
Histologically proven adenocarcinoma of the colon;
Confirmed eligibility for surgery with curative intent;
High expression of mesenchymal genes determined with diagnostic qPCR test;
WHO performance status 0 or 1.
Exclusion Criteria
The presence of synchronous distant metastases ;
Current hospital standard of care dictates that patient should undergo any neoadjuvant therapy;
Concurrent participation in another clinical trial using any medicinal product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>This study is designed as a proof-of-concept study with multiple outcomes of<br /><br>interest. The primary endpoint is the extent of treatment-induced changes in<br /><br>expression of genes associated with the poor-prognosis mesenchymal subtype.<br /><br>This will be evaluated by comparison of gene expression arrays from paired pre-<br /><br>and post-treatment tissue samples. </p><br>
- Secondary Outcome Measures
Name Time Method <p>We will further assess the relation between the pharmacokinetics of imatinib<br /><br>and the extent of target inhibition and changes in gene expression. Changes in<br /><br>circulating tumour DNA levels will be measured during treatment as a surrogate<br /><br>measure for change in tumour load. Finally, we will to study the effects of<br /><br>imatinib on tumour-derived organoid cultures. </p><br>