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A 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

ABSTRACT: Intervention1: Masitinib, FOLFIRI: Masitinib will be taken orally, daily at 6mg/kg/day. FOLFIRI will be administered every 2 weeks Control Intervention1: Placebo, FOLFIRI: Placebo will be taken orally, daily. FOLFIRI will be administered every 2 weeks Primary outcome(s): Overall Survival (OS)Timepoint: till death or last follow up Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded

DISEASE(S): Patients With Metastatic Colorectal Cancer

PROVIDER: 2577140 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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