Date: 2014-02-20
Type of information:
phase: 3
Announcement: initiation of the study
Company: AB Science (France)
Product: masitinib in combination with docetaxel
Action mechanism: 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: metastatic castrate resistant prostate cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This international, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study will compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC). The study will measure overall survival as a primary efficacy criterion. The phase 3 study has been authorized by competent authorities and will recruit 550 patients.
Latest
news: * On February 20, 2014, AB Science, a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors, has announced the initiation of a phase 3 study to evaluate the safety and efficacy of masitinib in combination with docetaxel in first line treatment of metastatic Castrate Resistant Prostate Cancer (mCRPC). The decision to move to phase 3 follows encouraging results from an exploratory phase 2 study of 34 patients in second line treatment of metastatic castrate resistant prostate cancer. The phase 2 tested the combination of masitinib with docetaxel, which had an acceptable safety profile. Median overall survival in the masitinib plus docetaxel treatment-arm reached 18.4 months, which compares favorably to a meta-analysis of OS of 13.8 months in second line treatment of mCRPC before the recent arrival of enzalutamide. With the arrival of enzalutamide (median OS 18.4 months) the median OS reaches 14.4 months. Because docetaxel is the standard of care in first line treatment of mCRPC, and because the combination of masitinib and docetaxel has an acceptable safety profile, the phase 3 study was designed in first line treatment.
