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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science

Criteria

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