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New Phase III Study Evaluates Masitinib in Prostate Cancer
Combo treatment with docetaxel viewed as first-line therapy (February 20)
A new randomized, double blind, placebo-controlled, phase III study has been initiated to compare the efficacy and safety of the tyrosine kinase inhibitor (TKI) masitinib in combination with docetaxel with that of placebo and docetaxel as first-line treatment in 550 men with metastatic castrate-resistant prostate cancer (mCRPC). The study’s primary efficacy endpoint is overall survival (OS).
The decision to proceed to a phase III trial followed encouraging results from an exploratory phase II study of masitinib and docetaxel as second-line treatment of mCRPC in 34 patients. The median OS in the masitinib-plus-docetaxel treatment arm was 18.4 months, which compared favorably with an OS of 13.8 months in a meta-analysis of second-line treatment of mCRPC.
Because docetaxel is the standard of care in first-line treatment of mCRPC, and because the combination of masitinib and docetaxel has shown an acceptable safety profile, the new phase III study has been designed to assess the combination’s efficacy and safety as first-line therapy.
According to the drug’s developer (AB Science), masitinib is an orally administered TKI that targets mast cells (important cells for immunity) as well as a limited number of kinases, which play key roles in various cancers. By inhibiting kinases that are essential in some oncogenic processes, masitinib may have an effect on tumor regression, alone or in combination with chemotherapy. In addition, through its effects on the mast cells and certain kinases essential to the activation of inflammatory cells and fibrotic tissue remodeling, masitinib may have an effect on symptoms associated with some inflammatory and central nervous system diseases.
Source: Globe Newswire; February 20, 2014.