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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Each patient will receive nilotinib 800 mg/day every day for 7 days. Study treatment will be taken twice a day (400 mg - 2 capsules) by oral route with an interval of approximately 12 hours between two doses and should not be taken with food. The entire capsule should be swallowed with water. No food should be consumed for 2 hours before taking the drug and for at least 1 hour after it.
Institut Bergonié
Bordeaux, France
ZAK expression level by immunohistochemistry on frozen material (surgical specimen) by Western blot and on paraffinembedded tissues section using an immunohistochemistry approach
Time frame: Day 0
ZAK expression level by immunohistochemistry on frozen material (surgical specimen) by Western blot and on paraffinembedded tissues section using an immunohistochemistry approach
Time frame: Day 7
Efficacy of the 7day nilotinib treatment based on histological response as measured with tumour regression grade
Time frame: Day 7
Efficacy of the 7day nilotinib treatment based on histological response as measured with the proportion of tumour necrosis
Time frame: Day 7
Efficacy of the 7day nilotinib treatment based on histological response as measured with the type of tumour necrosis
Time frame: Day 7
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v4.0 as assessed by CTCAE v4.0
Time frame: through study completion, an average of 2 years
Postoperative complications as assessed by Dindo and Clavien classification
Time frame: through study completion, an average of 2 years
Maximum Plasma Concentration [Cmax] of nilotinib .
Time frame: Day 7, day 8
Half-life of nilotinib
Time frame: Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.