Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

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.

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