A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
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ClinicalTrials.gov Identifier: NCT01506336
Recruitment Status : Unknown
Verified September 2012 by AB Science. Recruitment status was: Active, not recruiting
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
Study Start Date :
Actual Primary Completion Date :
Estimated Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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