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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
219
Tyrosine kinase inhibitor
University Hospital Olomouc
Olomouc, Czechia
Chu - Hopitaux de Rouen
Rouen, France
Omsk Clinical oncology dispensary
Omsk, Russia
Hospital Madrid Norte San Chinarro
Madrid, Spain
Overall survival
Overall survival (0S) 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 rates
Survival rate, 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 (PFS) 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, whichever came first, assessed up to 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hammersmith Hospital Imperial College Healthcare Nhs Trust
London, United Kingdom