Date: 2015-03-27
Type of information: Clinical trial authorization
phase: 3
Announcement: clinical trial authorization
Company: AB Science (France)
Product: masitinib
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor
Disease: refractory peripheral T-cell lymphoma
Therapeutic area: Cancer - Oncology
Country: France
Trial
details: The prospective,multicenter, randomised, open-label, three-parallel groups, phase 2 study evaluates the efficacy and safety of masitinib with dexamethasone, gemcitabine with dexamethasone and the combination of masitinib, gemcitabine and dexamethasone in patients with relapsed or refractory peripheral T-cell lymphoma.
Patients will be randomized in three groups:
Group 1: Patients will receive masitinib orally at 7.5 mg/kg/day twice daily in combination with dexamethasone
Group 2: Patients will receive dexamethasone in combination with gemcitabine
Group 3: Patients will receive masitinib orally at 6 mg/kg/day twice daily in combination with
dexamethasone and gemcitabine.
The primary criterion will be the Overall Progression Free Survival (PFS), defined as the delay between the date of randomisation to the date of documented progression or any cause of death during the study.
Latest
news: * On May 27, 2015, AB Science announced that its phase 2 with masitinib in relapsed or refractory peripheral T-cell lymphoma (PTCL) was accelerated into a phase 3 randomized controlled trial. This phase 2-3 study is a prospective, multicenter, open-label, three-parallel groups, randomized trial to evaluate the efficacy and safety of masitinib plus dexamethasone with or without gemcitabine, as compared against the active control of dexamethasone plus gemcitabine, in patients with relapsed or
refractory peripheral T-cell lymphoma. The primary endpoint of this study is overall survival.
The clinical development program of masitinib in peripheral T-cell lymphoma started with a phase 2, open label, three-parallel groups, randomized study, which involved the planned recruitment of 45 patients.
Health authorities from 14 countries agreed to transform the phase 2 study directly into phase 3, with prospective recruitment of 270 patients.
The decision to accelerate the phase 2 into phase 3 was based on the observation of a survival benefit with masitinib as compared to control (data blinded to sponsor and investigator) and acceptable safety with validation of the passage into phase 3 by the independent Data Monitoring Safety Board.
