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

AB Science

Status and phase: Terminated; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: FOLFIRI; Drug: Masitinib (AB1010)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02605044

AB12006

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 2 patient groups, including a placebo group

Masitinib + FOLFIRI

Experimental group

Description:

masitinib + FOLFIRI

Treatment:

Drug: FOLFIRI

Drug: Masitinib (AB1010)

Placebo + FOLFIRI

Placebo Comparator group

Description:

Placebo + FOLFIRI

Treatment:

Drug: FOLFIRI