Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
Phase 2
Completed
- Conditions
- Gastro Intestinal Stromal Tumor
- Interventions
- Registration Number
- NCT01506336
- Lead Sponsor
- AB Science
- Brief Summary
The objective is 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Histological proven, metastatic, or locally advanced and non-operable GIST
- Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
- C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
- Patients resistant to imatinib at dose of 400 mg/day
Exclusion Criteria
- 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
- Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description masitinib masitinib masitinib 12 mg/kg/day sunitinib sunitinib sunitinib 50 mg/day
- Primary Outcome Measures
Name Time Method overall progression free survival up to 36 weeks 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
- Secondary Outcome Measures
Name Time Method overall survival up to 36 weeks From date of randomization until the date of death from any cause, assessed up to 36 weeks
Trial Locations
- Locations (1)
Institute Gustave Roussy (IGR)
🇫🇷Villejuif, France