masitinib vs irinotecan in advanced esophagogastric adenocarcinoma V1
Research type
Research Study
Full title
A prospective, multicentre, double-blind, randomized, placebo-controlled, phase 3 study to evaluate efficacy and safety of masitinib with irinotecan in patients with advanced-stage esophagogastric adenocarcinoma who have relapsed after first-line chemotherapy
IRAS ID
191718
Contact name
Alain Moussy
Contact email
Sponsor organisation
AB Science
Eudract number
2015-000897-36
Clinicaltrials.gov Identifier
IND: 113 689, Investigational New Drug (IND) Application
Duration of Study in the UK
3 years, 0 months, 30 days
Research summary
Esophagogastric Cancer (commonly called stomach/gastric cancer) is very aggressive disease. Adenocarcinoma is the most common type with high death rate representing 90% of all stomach cancer deaths. Cancer is caused by modification of some cells that turn into cancer cells. These changes are called genetic mutations. The reason for these changes is unknown but some genes such as cKit or platelet derived growth factor receptor (PDGFR) are involved. When cancer cells are found in other organs, the cancer is called metastatic.
Indeed, it has become clear that some human diseases are the result of a fault in communication between cells. A category of enzymes plays a basic role in cell signal transmission. In diseases such as Esophagogastric Cancer, these enzymes do not function properly. Specific drugs (such as masitinib) can block malfunctioning enzymes and thus help to treat the diseases.
Masitinib is a novel protein-tyrosine kinase inhibitor which, in vitro, potently and selectively inhibits a mutated form of the c-Kit receptor as well as the PDGFR in the same range of concentrations.
This phase 3 study will evaluate the efficacy and safety of masitinib in combination with irinotecan in comparison to placebo in combination with irinotecan in 2nd line
advanced gastric cancer.
The study will be carried out in 364 patients with advanced esophagogastric adenocarcinoma. Patients will be randomly chosen to go into 2 groups of 182 patients: Group 1 patients will receive 6mg/kg/day masitinib + irinotecan and Group 2 patients will receive placebo + irinotecan.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0284
Date of REC Opinion
30 Jun 2016
REC opinion
Unfavourable Opinion