This study aims to compare the efficienty and safety of masitinib at a dose of 12 mg/kg/dag to those of a standard treatment for GIST: sunitinib (Sutent) 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 (Glivec)
- Conditions
- stromal gastrointestinal cancerMedDRA version: 19.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001790-41-NL
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- 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 up to 800mg
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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1. patient treated for a cancer other vthan GIST within 5 years before enrolmentwith the exception of basal cell carcinoma or cervical cancer in situ
2. patient with active CNS metastasis or with history of CNS mtastasis
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 20 mg/kg/day in comparison with sunitinib 50mg/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