A prospective, multicenter, randomised, open-label, active controlled, 2 parallel groups, phase 3 study to compare the efficay and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imitinib
- Conditions
- 10017991gastro-intestinal stomal tumor (GIST)10017990
- Registration Number
- NL-OMON44774
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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;
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>- time to treatment failure,<br /><br>- overall progression free survival rate at weeks 8, 16, 24 and then every 12<br /><br>weeks<br /><br>- survival rate at weeks 8, 16, 24 and the every 12 weeks<br /><br>- overall time to progression<br /><br>- time to progression rate at weeks 8, 16, 24 and then every 12 weeks<br /><br>- best response<br /><br>- best response rate<br /><br>- objective response<br /><br>- objective response rate<br /><br>- disease control<br /><br>disease control rate at weeks 8, 16, 24 and then every 12 weeks</p><br>