Date: 2015-03-30
Type of information: DSMB assessment
phase: 2
Announcement: DSMB assessment
Company: AB Science (France)
Product: masitinib
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor
Disease: head and neck squamous cell 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 irinotecan or masitinib in combination with gemcitabine in patients with a recurrent and/or metastatic head and neck squamous cell carcinoma in second or third line of treatment. The study’s primary endpoint is overall survival.There are three objectives: i) To determine if masitinib can be safely combined with chemotherapy in this indication. ii) To determine if the study meets the pre-defined statistical hypothesis to detect a trend of superiority on OS as compared with the latest benchmark in this indication. This statistical test is based on the upper bound for the confidence interval of Hazard Ratio, estimated from the median OS observed in this phase 2 study and the historical benchmark. iii) To determine which combination has the best benefit-risk balance if any. Achieving these three objectives is considered a prerequisite for progressing into phase 3 development.
Latest
news: * On March 30, 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 or third line of treatment of head and neck squamous cell carcinoma 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 irinotecan or masitinib in combination with gemcitabine in patients with a recurrent and/or metastatic head and neck squamous cell carcinoma in second or third line of treatment. The study’s primary endpoint is overall survival. This recommendation from the DSMB confirms that the safety for the combination of masitinib with irinotecan or gemcitabine is acceptable based on the data currently generated in this study.
