Masitinib in Metastatic Colorectal Cancer phase II V1.0
Research type
Research Study
Full title
A prospective, multicentre, open-label, randomized, active-controlled, 3 parallel groups, phase 2 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid), versus masitinib alone, versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer
IRAS ID
165592
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
AB Science
Eudract number
2013-000493-30
Duration of Study in the UK
1 years, 7 months, 30 days
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 compare the efficacy and safety of masitinib in combination with FOLFIRI(irinotecan, 5-fluorouracil and folinic acid) compared to masitinib alone versus Best Supportive Care in third or fourth line treatment of patients with metastatic colorectal cancer.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0461
Date of REC Opinion
29 Oct 2015
REC opinion
Unfavourable Opinion