Date: 2011-10-17
Type of information: Initiation of preclinical development
phase: 3
Announcement: recruitment of the first patient
Company: AB Science (France)
Product: masitinib
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor
Disease: multiple myeloma
Therapeutic area:
Country:
Trial
details: This is an international, multicenter, randomized, double-blind, controlled, phase 3 study. Its objective is to investigate the efficacy and safety of masitinib at 6 mg/kg/day in combination with bortezomib (Velcade®) and dexamethasone as compared with that of a placebo in combination with bortezomib and dexamethasone, in the treatment of patients with relapsing multiple myeloma who have previously received a first line of therapy. This study will enroll approximately 300 patients, across 75 centers around the world, randomized with a ratio of 1:1 between the masitinib/bortezomib/dexamethasone and the placebo/bortezomib/dexamethasone groups. The primary response evaluation will be the Overall Progression Free Survival progression free survival (PFS).
Latest
news: * On October 17, 2011, AB Science has announced recruitment of the first patient in the phase 3 study of masitinib in the treatment of patients with relapsing multiple myeloma who received one previous therapy. AB Science is now conducting 8 phase 3 studies.
