Status:
COMPLETED
Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
Lead Sponsor:
AB Science
Conditions:
Gastro Intestinal Stromal Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01506336
Start Date
October 1 2008
End Date
April 1 2012
Last Update
December 11 2018
Active Locations (1)
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1
Institute Gustave Roussy (IGR)
Villejuif, France, 94815