This trial is active, not recruiting.

Condition gastro-intestinal stromal tumours
Treatment oral masitinib
Phase phase 2
Sponsor AB Science
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
oral masitinib 7.5 mg/kg/day
oral masitinib AB1010
7.5 mg/kg/day

Primary Outcomes

Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)
time frame: 2 months

Secondary Outcomes

Progression Free Survival
time frame: until disease progression

Eligibility Criteria

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

Additional Information

Official title Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by AB Science.