NCT01694277

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (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 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

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 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Masitinib	12 mg/kg/day
DRUG	Sunitinib	50 mg/day

Timeline

• Start date: 2012-04-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2012-09-27
• Last updated: 2020-12-08

Locations

5 sites across 4 countries: United States, France, Italy, Netherlands