Masitinib vs Imatinib in first line metastatic GIST - AB04030 v4.0 UK2
Research type
Research Study
Full title
A prospective, multicentre, randomized, open-label, active-controlled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment
IRAS ID
63743
Contact name
Michael Leahy
Eudract number
2008-000973-40
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Gastro-intestinal stromal tumours (GIST) are uncommon visceral sarcomas that arise in the stomach (60-70%), small intestine (20-30%), colon and rectum (5%) and oesophagus (<5%). GISTs are associated with major resistance to conventional chemotherapy and with a poor prognosis in the advanced stage of disease. Masitinib has been shown to be highly effective in patients with advanced GIST in phase II clinical trials. Non-comparative data suggests that disease control with Masitinib is equivalent or possibly superior to that obtained with Imatinib.The objective of this clinical trial is to compare the safety and efficacy of Masitinib to Imatinib (medication for standard treatment) in patients with metastatic or locally advanced gastro-intestinal stromal tumour in first line medical treatment. The patients will be randomised in two groups. Each group will consist of 111 patients. Group 1 will receive Masitinib at 7.5mg/kg/day and group 2 Imatinib at 400 mg/day. The recruitment phase will take 36 months and patients will be treated until disease progression. In this phase III study, around 60 sites in Europe and USA are involved.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
11/NW/0080
Date of REC Opinion
23 Jun 2011
REC opinion
Further Information Favourable Opinion