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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02605044
• Other study ID #: AB12006
• Status: Terminated
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2019
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Masitinib (AB1010)

• FOLFIRI

Locations

Country	Name	City	State
France	Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc	Paris
Singapore	National Cancer Center, 11 Hospital Drive	Singapore
United Kingdom	Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road	London

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

France,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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