Back to resultsMasitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib (AB1010)
FOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
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.
Sites / Locations
- Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc
- National Cancer Center, 11 Hospital Drive
- Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Masitinib + FOLFIRI
Placebo + FOLFIRI
Arm Description
masitinib + FOLFIRI
Placebo + FOLFIRI
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Survival rate
Survival rate is defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02605044
Brief Title
Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib + FOLFIRI
Arm Type
Experimental
Arm Description
masitinib + FOLFIRI
Arm Title
Placebo + FOLFIRI
Arm Type
Placebo Comparator
Arm Description
Placebo + FOLFIRI
Intervention Type
Drug
Intervention Name(s)
Masitinib (AB1010)
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Primary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
From day of randomization to death, assessed for a maximum of 60 months
Secondary Outcome Measure Information:
Title
Survival rate
Description
Survival rate is defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Time Frame
Every 24 weeks, assessed up to 60 months
Title
Progression Free Survival (PFS)
Description
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
Time Frame
From day of randomization to disease progression or death, assessed for a maximum of 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Taieb, PhD, MD
Organizational Affiliation
Hôpital Européen Georges Pompidou, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc
City
Paris
ZIP/Postal Code
75
Country
France
Facility Name
National Cancer Center, 11 Hospital Drive
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer
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