Clinical trial NCT02605044: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2015-11-16
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall survival
timeFrame: From day of randomization to death, assessed for a maximum of 60 months
Secondary outcomes:
measure: Survival rate
timeFrame: Every 24 weeks, assessed up to 60 months
measure: Progression Free Survival (PFS)
timeFrame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc
city: Singapore
country: Singapore
facility: National Cancer Center, 11 Hospital Drive
city: London
country: United Kingdom
facility: Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road
Study officials:
affiliation: Hôpital Européen Georges Pompidou, Paris, France
name: Julien Taieb, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: