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Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer — ZAK-0  

Colon Cancer Clinical Trial

Official title:
Phase 0 Study Aiming at Identifying Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer

Clinical Trial Summary

This is a monocentric prospective non randomized phase 0 clinical trial targeting patients with colon cancer for whom an upfront surgery has been advised by the pluridisciplinary team.

Clinical Trial Description

This is a monocentric prospective non randomized phase 0 clinical trial targeting patients with colon cancer for whom an upfront surgery has been advised by the pluridisciplinary team. The surgical management should not be changed or delayed. The patient is seen in consultation by one of the two surgeons. The patient receives information and consents to participate to the study. A specific colonoscopy is performed in order to take biopsy for biological studies. According to the expression level of ZAK-0, the patient is included in the corresponding arm: ZAK-0 expressor or ZAK-0 non-expressor. Then the patient receives nilotinib orally at the dose of 800 mg/day (400 mg twice a day) for 7 days. The patient is scheduled for surgery the morning after the last take of the nilotinib (12 hours). When the colectomy is performed, the surgeon collects different tumoral samples which are immediately delivered to the laboratory. There are no additional changes in the clinical follow up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02774512
Study type Interventional
Source Institut Bergonié
Contact
Status Withdrawn
Phase Early Phase 1
Start date May 2016
Completion date November 2017
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