Gastro-Intestinal Stromal Tumour Clinical Trial
Official title:
A Prospective, Multicenter, Randomised, Double-blinded, Placebo-controlled, Two-parallel Groups, Phase III Study to Compare the Efficacy and Safety of Masitinib to Placebo in Patients With Localized, Primary Gastrointestinal Stromal Tumor (GIST) After Complete Surgery and With High Risk of Recurrence
The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day to placebo in the treatment of patients with localized, primary gastrointestinal stromal tumor (GIST) after complete surgery and with high risk of recurrence.
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day with respect to placebo in the treatment of patients with localized, primary gastrointestinal stromal tumor (GIST) after complete surgery and with high risk of recurrence. ;