Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer
- Registration Number
- NCT03556956
- Lead Sponsor
- AB Science
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Masitinib plus FOLFIRI Masitinib Masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid). Masitinib will be prescribed until disease progression (or treatment switch to next line of treatment), death, limiting toxicity or patient consent withdrawal.
- Primary Outcome Measures
Name Time Method Overall survival From day of randomization to death, assessed for a maximum of 60 months 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.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) From day of randomization to disease progression or death, whichever came first, assessed up to 60 months 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.
Survival rates Every 24 weeks, assessed up to 60 months Survival rate, defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Trial Locations
- Locations (5)
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Chu - Hopitaux de Rouen
🇫🇷Rouen, France
Hospital Madrid Norte San Chinarro
🇪🇸Madrid, Spain
Hammersmith Hospital Imperial College Healthcare Nhs Trust
🇬🇧London, United Kingdom
Omsk Clinical oncology dispensary
🇷🇺Omsk, Russian Federation