GIST phase III -- Phase III Study to Compare the Efficacy and Safety of Masitinib to Placebo in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of recurrence Condition: Gastro-Intestinal Stromal Tumour

Not yet recruiting

Masitinib vs Placebo - Phase III Study to Compare the Efficacy and Safety of Masitinib to Placebo in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of recurrence
Condition: Gastro-Intestinal Stromal Tumour
Interventions: Drug: Masitinib; Drug: Placebo
Study Type: Interventional
Phase: Phase 3
Sponsor: AB Science
Funder Type: Industry
Study Design: Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment; Masking: Double Blind (Subject, Investigator)
Outcome Measures: Recurrence Free Survival (RFS); Overall Survival (OS); Time To Recurrence (TTR); Quality of Life; Safety profile
Number Enrolled: 330
Gender: Both
Age Groups: Adult / Senior
NCT Number: NCT02009423
Other IDs: AB12004
Title Acronym:
Study Start: January 2014
Primary Completion: March 2014
Study Completion: December 2016
First Received: November 28, 2013
Last Updated: December 9, 2013
Last Verified: December 2013
Results First Received: No Study Results Posted


http://clinicaltrials.gov/ct2/results/displayOpt?flds=a&flds=b&flds=i&flds=f&flds=c&flds=h&flds=j&flds=t&flds=g&flds=d&flds=e&flds=k&flds=l&flds=r&flds=n&flds=s&flds=o&flds=m&flds=p&flds=q&flds=u&submit_fld_opt=on&term=Masitinib&;show_flds=Y