A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer

The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care in third or fourth line treatment of patients with metastatic colorectal cancer.

Inclusion Criteria:

• Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum.
• Patient in third line or fourth line of treatment for metastatic colorectal cancer.
• Patient with measurable lesions according to RECIST criteria (version 1.1).
• Patient with ECOG equal to or less than 2.
• Patient with adequate organ function
• Other inclusion criteria may also apply

Exclusion Criteria:

• Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib.
• More than 3 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, with the exception of basal cell carcinoma or cervical cancer in situ.
• Other exclusion criteria may also apply