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 ]

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed 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 ]

From date of randomization until the date of death from any cause, assessed 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