Colorectal Cancer Metastatic
Conditions
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.
Interventions
DRUGMasitinib
Tyrosine kinase inhibitor
Sponsors
AB Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicentre, open-label, randomized, parallel groups, seamless 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 of treatment of patients with metastatic colorectal cancer.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Czechia, France, Russia, Spain, United Kingdom
Outcome results
None listed