Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science

Criteria

Inclusion Criteria:

• Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum.

• Patient in third line or fourth line of treatment for metastatic colorectal cancer.

• Patient with measurable lesions according to RECIST criteria (version 1.1).

• Patient with ECOG equal to or less than 2.

• Patient with adequate organ function

• Other inclusion criteria may also apply

Exclusion Criteria:

• Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib.

• More than 3 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, with the exception of basal cell carcinoma or cervical cancer in situ.

• Other exclusion criteria may also apply