Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Masitinib in Combination With FOLFIRI Versus Masitinib Alone, Versus Best Supportive Care, in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Drug: Masitinib


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria may also apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masitinib plus FOLFIRI<br>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. | Drug: Masitinib<br>* Tyrosine kinase inhibitor<br>* Other names: AB1010;|
| No Intervention: Best Supportive Care<br>Best Supportive Care (BSC) includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From day of randomization to death, assessed for a maximum of 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rates | Survival rate, defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution | 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. | From day of randomization to disease progression or death, whichever came first, assessed up to 60 months |