A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
This trial is active, not recruiting.
|Condition||gastro-intestinal stromal tumours|
|Start date||June 2005|
|End date||January 2014|
|Trial size||30 participants|
|Trial identifier||NCT00998751, AB04016|
The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
oral masitinib 7.5 mg/kg/day
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)
time frame: 2 months
Progression Free Survival
time frame: until disease progression
Male or female participants at least 18 years old.
Inclusion Criteria: - Male or Female patients, age >18 - Life expectancy > 6 months - Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST. - Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy - C-Kit (CD117) positive tumors detected immuno-histochemically - Measurable tumor lesions with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan Exclusion Criteria: - Documented allergy to the similar drug of AB1010 - Inadequate organ function - Patients with a history of any other malignancy
|Official title||Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)|
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