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

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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: FOLFIRI; Drug: Masitinib (AB1010)

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75
    • Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc
• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Center, 11 Hospital Drive
• United Kingdom
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Masitinib + FOLFIRI; masitinib + FOLFIRI	Drug: FOLFIRI; Drug: Masitinib (AB1010)
Placebo Comparator: Placebo + FOLFIRI	Drug: FOLFIRI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AB Science
• Investigators: Principal Investigator: Julien Taieb, PhD, MD, Hôpital Européen Georges Pompidou, Paris, France

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: AB12006