This study aims to compare the efficiency and safety of masitinib at a dose of 12 mg/kg/dag to those of a standard treatment for GIST: sunitinib (Sudent) at a dose of 50 mg/day for 4 consecutive weeks followed by weeks without medication. Masitinib and sunitinib will be administred untill disease progression in patients with GIST after receiving standard: imatinib (Glivac)
- Conditions
- MedDRA version: 18.1 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001790-41-DE
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 350
1. patient with histological proven metastatic GIST (gastro-intestinal stromal cancer) or non-operable locally advanced GIST
2. patient with measurable tumor lesions with longest diameter >=20 mm using conventional techniques or >= 10 mm with spiral CT scan according to Recist 1.1
3. patient with C-kit (CD117) positive tuimour detected immunohistochemically
4. patient after progression with imatinib
5. patient with ECOG <=2
6.Patient with adequate organ functions
7. patient with life expectancy >3 months
8. male or female > 18 years
9. patient with a BMI > 18 kg/m2 and weightening at least 40 kg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. patient treated for a cancer other than GIST within 5 years before enrolment with the exception of basal cell carcinoma or cervical cancer in situ
2. patient with active CNS metastasis or with history of CNS metastasis
3. patient with certain cardiac disorder
4.patient with history of poor compliance or history of drug/alcohol abuse or excessive alcohol beverage consumption
5. pregnant or nursing female
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective: the efficacy of masitinib 12 mg/kg/day in comparison with sunitinib 50 mg/day in patients with stromal gastrintestinal cancer previously progressed after treatment with imatinib;Secondary Objective: Secondary objectives: safety and quality of life;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: week 24
- Secondary Outcome Measures
Name Time Method