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

Phase 3

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Masitinib (AB1010); Drug: FOLFIRI

• Registration Number: NCT02605044
• Lead Sponsor: AB Science

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-16
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Disposition First Submitted: 2019-01-25
• Disposition First Submitted QC: 2019-01-25
• Disposition First Posted: 2019-01-28
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Masitinib + FOLFIRI	FOLFIRI	masitinib + FOLFIRI
Placebo + FOLFIRI	FOLFIRI	Placebo + FOLFIRI
Masitinib + FOLFIRI	Masitinib (AB1010)	masitinib + FOLFIRI

Primary Outcome Measures

Name	Time	Method
Overall survival	From day of randomization to death, assessed for a maximum of 60 months	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

Name	Time	Method
Survival rate	Every 24 weeks, assessed up to 60 months	Survival rate is 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, assessed for a maximum of 60 months	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

Trial Locations

Locations (3)

National Cancer Center, 11 Hospital Drive; 🇸🇬 Singapore, Singapore

Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc; 🇫🇷 Paris, France

Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road; 🇬🇧 London, United Kingdom