Clinical Trial: A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Imatinib in Patients With Gastro-Intestinal Stromal Tumour in First Line Medical Treatment

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Tr

Brief Summary: The objective of the study is to compare the efficacy and safety of masitinib to imatinib in patients with gastro-intestinal stromal tumour (GIST) in first line medical treatment.

Detailed Summary: GISTs are uncommon visceral sarcomas that arise predominantly in the gastro-intestinal tract. Most GIST cells are positive for c-kit (CD117), a cell surface antigen corresponding to the Stem Cell Factor (SCF) receptor. The receptor has an intracellular tyrosine kinase (TK) joined by a juxtamembrane domain. It is hypothesized that all malignant GIST cells harbor a mutation of c-kit, resulting in the activation of c-kit and cell division and tumour growth. Drugs that can selectively inhibit TKs are likely to be of benefit in GISTs. Masitinib (AB1010) is a TK inhibitor, selectively and effectively inhibiting c-kit. Imatinib is also a TK inhibitor indicated in the treatment of GIST. It might be associated with side effects and patients might develop a resistance to treatment over time. Based on pre-clinical and clinical studies, masitinib (AB1010) can be considered as a good candidate in the first line treatment of patients with GIST.
Sponsor: AB Science

Current Primary Outcome: Progression Free Survival [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Overall survival [ Time Frame: 24 months ]

Original Secondary Outcome: Same as current

Information By: AB Science

Dates:
Date Received: December 19, 2008
Date Started: January 2009
Date Completion: December 2013
Last Updated: September 25, 2012
Last Verified: September 2012