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

AB Science

Status and phase: Completed; Phase 2

Conditions: Gastro-intestinal Stromal Tumours

Treatments: Drug: oral masitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00998751

AB04016

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

masitinib (AB1010)

Experimental group

Description:

oral masitinib 7.5 mg/kg/day

Treatment:

Drug: oral masitinib