NCT00812240

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

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. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Masitinib
DRUG	Imatinib	imatinib 400 mg or 600 mg per day, per os

Timeline

• Start date: 2009-01-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2008-12-22
• Last updated: 2023-02-01

Locations

41 sites across 3 countries: United States, France, Lebanon

Regulatory

• FDA-regulated drug study