Clinical Trial: A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatme
Brief Summary: The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.
Detailed Summary:
Sponsor: AB Science
Current Primary Outcome: overall progression free survival [ Time Frame: up to 36 weeks ]
Original Primary Outcome: overall progression free survival [ Time Frame: until progression (after median follow up of 6 months) ]
Current Secondary Outcome: overall survival [ Time Frame: up to 36 weeks ]
Original Secondary Outcome: overall survival [ Time Frame: until death (up to median survival of 12 months) ]
Information By: AB Science
Dates:
Date Received: January 3, 2012
Date Started: October 2008
Date Completion: December 2013
Last Updated: September 25, 2012
Last Verified: September 2012