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

A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With FOLFIRI (Irinotecan, 5-fluorouracil and Folinic Acid) to Placebo in Combination With FOLFIRI in Second 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) to placebo in combination with FOLFIRI in second line treatment of patients.

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.