NCT02009423

Masitinib in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of Recurrence

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastro-Intestinal Stromal Tumour

Interventions

Type	Name	Description
DRUG	Masitinib
DRUG	Placebo

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-12-12
• Last updated: 2018-12-14

Regulatory

• FDA-regulated drug study