Trial Information
A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib
Inclusion Criteria:
1. Histological proven, metastatic, or locally advanced and non-operable GIST
2. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques
or ≥ 10 mm with spiral CT scan according RECIST criteria
3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation
of c-kit at any time if available
4. Patients resistant to imatinib at dose of 400 mg/day
Exclusion Criteria:
1. Patient treated for a cancer other than GIST cancer within 5 years before enrolment,
with the exception of basal cell carcinoma or cervical cancer in situ
2. Patient with active central nervous system (CNS) metastasis or with history of CNS
metastasis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall progression free survival
Outcome Description:
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
Outcome Time Frame:
up to 36 weeks
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
AB07001
NCT ID:
NCT01506336
Start Date:
October 2008
Completion Date:
December 2013
Related Keywords:
- Gastro Intestinal Stromal Tumor
- GIST
- resistant
- imatinib
- gastro intestinal stromal tumor resistant to imatinib
- Gastrointestinal Stromal Tumors