Date: 2015-01-22
Type of information: DSMB assessment
phase: 2
Announcement: DSMB assessment
Company: AB Science (France)
Product: masitinib in combination with gemcitabine or carboplatin or capecitabine
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The study’s 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 with the latest benchmark in this indication, to determine which combination has the best benefit-risk balance if any and to determine the optimum dose regimen of the masitinib plus chemotherapy combination. Achieving these three objectives is considered a prerequisite for progressing into phase 3 development.
Latest
news: * On January 22, 2015, AB Science announced that the external Data and Safety Monitoring Board (DSMB) has recommended continuation of its phase 2 study assessing masitinib in second-line treatment of breast cancer based upon review of the latest safety and efficacy data. The objective of this phase 2 study is to evaluate the safety and efficacy of masitinib in combination with gemcitabine or carboplatin or capecitabine in patients with metastatic or locally advanced breast cancer and who had relapsed after first-line chemotherapy.
