Masitinib/Placebo + FOLFIRI in Metastatic Colorectal Cancer V1.0
Research type
Research Study
Full 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
IRAS ID
152229
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
AB Science
Eudract number
2013-000490-79
Research summary
Colon and rectal cancers represent the third most common cancer in both men and women. When the cancer is detected at an early, localized stage, the 5-year survival is 90%. After the cancer has spread regionally to involve adjacent organs or lymph nodes, the 5-year survival drops to 68%. For patients with distant metastases (the spread of a cancer from one organ or part to another non-adjacent organ or part), the 5-year survival is less than 10%. The risk of colorectal cancer is increased by certain inherited genetic mutations, a personal or family history of colorectal cancer/polyps or a personal history of chronic inflammatory bowel disease. Current therapies include Surgery, Chemotherapy, Radiation therapy, Immunotherapy and vaccines.
Masitinib is a potent inhibitor of mast cell activity. A growing number of studies corroborate the role of mast cells in the remodelling of the microenvironment around various tumour types. Indeed, mast cell activation has been implicated in several tumour cells. Mast cells infiltrate into the boundary between normal tissue and tumours, acting as pro-angiogenic agents (promoting the formation of new blood vessels allowing tumours to grow and spread) and releasing different mediators. These mediators promote inflammation, matrix destruction, tissue remodelling, and favour the production of immunosuppressive cytokines and chemokines. Therefore, masitinib might inhibit specifically the remodelling of the tumour microenvironment by blocking the activation mast cells, thereby preventing tumour growth, differentiation, and survival of these cells. Other research indicates that Masitinib is able to sensitize colorectal tumour cell lines to cytotoxic agents. Masitinib has great potential in combination therapy with standard chemotherapy treatments of colorectal cancers. The study aims to compare survival rates of patients with colorectal cancer receiving as second line therapy; masitinib + FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) against a control group of patients who will receive placebo (tablets containing no drug) + FOLFIRI.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1055
Date of REC Opinion
1 Sep 2014
REC opinion
Further Information Favourable Opinion