Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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) to placebo in combination with FOLFIRI in second line treatment of patients.

Official Title
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A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study 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 With Metastatic Colorectal Cancer

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Masitinib (AB1010)
* Drug: FOLFIRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with non-resectable metastatic colorectal cancer Metastatic disease not amenable to surgical resection Patient in second line treatment after progression according to RECIST criteria Patient with measurable lesions according to RECIST criteria (version 1.1) Patient eligible for a standard second line treatment with FOLFIRI Patient with ECOG ≤ 2 Patient with adequate organ function Patient with life expectancy > 3 months Female or male patient ≥ 18 Patient weight > 40 kg and BMI > 18 Exclusion Criteria: Patient who cannot receive FOLFIRI More than 1 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 Patient with an hepatic involvement > 50% Patient with active central nervous system (CNS) metastasis or history of CNS metastases Patient with an active infection Patient presenting with cardiac disorders Any previous treatment with an investigational agent or chemotherapy or biological agent within four weeks prior to baseline.

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masitinib + FOLFIRI<br>masitinib + FOLFIRI | Drug: Masitinib (AB1010)<br> <br> Drug: FOLFIRI<br> <br> |
| Placebo Comparator: Placebo + FOLFIRI<br>Placebo + FOLFIRI | Drug: FOLFIRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival rate is 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 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, assessed for a maximum of 60 months |