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

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science

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.