Masitinib in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of Recurrence
- Sponsor
- AB Science
- Study ID
- NCT02009423
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Gastro-Intestinal Stromal Tumour
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Masitinib — DRUG
- Placebo — DRUG
Study Details
The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day to placebo in the treatment of patients with localized, primary gastrointestinal stromal tumor (GIST) after complete surgery and with high risk of recurrence.
Key Dates
- Start date
- Jul 31, 2015
- Status verified
- Dec 2018
- Primary completion
- Nov 30, 2015
- Completion
- Nov 30, 2015
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Masitinibmasitinib-treatment arm
- Placebo Comparator: Placeboplacebo-treatment arm
Primary Outcome Measure
Recurrence Free Survival (RFS) [ Time Frame: Until tumor recurrence (e.g. up to 24 months) ]