Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer

Inclusion Criteria:

* Patient with non-resectable metastatic colorectal cancer
* Metastatic disease not amenable to surgical resection
* Patient in second line treatment after progression according to RECIST criteria
* Patient with measurable lesions according to RECIST criteria (version 1.1)
* Patient eligible for a standard second line treatment with FOLFIRI
* Patient with ECOG ≤ 2
* Patient with adequate organ function
* Patient with life expectancy \> 3 months
* Female or male patient ≥ 18
* Patient weight \> 40 kg and BMI \> 18

Exclusion Criteria:

* Patient who cannot receive FOLFIRI
* More than 1 prior chemotherapy regimens for metastatic colorectal cancer
* Pregnant, intent to be pregnant, or nursing female patient
* Patient with any chronic inflammatory bowel disease
* Patient treated for a cancer other than colorectal cancer within five years before enrollment
* Patient with an hepatic involvement \> 50%
* Patient with active central nervous system (CNS) metastasis or history of CNS metastases
* Patient with an active infection
* Patient presenting with cardiac disorders
* Any previous treatment with an investigational agent or chemotherapy or biological agent within four weeks prior to baseline.