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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc
Paris, France
National Cancer Center, 11 Hospital Drive
Singapore, Singapore
Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road
London, United Kingdom
Overall survival
Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.
Time frame: From day of randomization to death, assessed for a maximum of 60 months
Survival rate
Survival rate is defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Time frame: Every 24 weeks, assessed up to 60 months
Progression Free Survival (PFS)
Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria
Time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
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