Date: 2014-11-12
Type of information: DSMB assessment
phase: 2
Announcement: DSMB assessment
Company: AB Science (France)
Product: masitinib in combination with etoposide, or with irinotecan
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor. Masitinib is a tyrosine kinase inhibitor that targets mast cells, important cells for immunity, as well as a limited number of kinases that play key roles in various cancers.
Disease: advanced hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The objective of this phase 2 study is to evaluate the safety and efficacy of masitinib in combination with etoposide, or masitinib in combination with irinotecan in patients with advanced hepatocellular carcinoma and who relapsed after a first line therapy with sorafenib. The study primary endpoint is overall survival. There are three objectives: to determine if at least one combination has a trend of superiority on overall survival as compared to the latest benchmark in this indication, to determine which combination has the
best benefit/risk if any, to determine the best dose of both masitinib and chemotherapies. Those threeobjectives are considered pre requisite to move into phase 3.
Latest
news: * On November 12, 2014, AB Science announced that the external Data and Safety Monitoring Board (DSMB) has recommended the continuation of its phase 2 study of masitinib in advanced hepatocellular carcinoma based upon review of the latest safety and efficacy data.
