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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00998751
• Date of registration: 19/10/2009
• Prospective Registration: No
• Primary sponsor: AB Science
• Public title: Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
• Scientific title: Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
• Date of first enrolment: June 2005
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00998751
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastro-intestinal Stromal Tumours

Intervention(s)

Drug: oral masitinib

Primary Outcome(s)

Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) [Time Frame: 2 months]

Secondary Outcome(s)

Progression Free Survival [Time Frame: until disease progression]

Secondary ID(s)

AB04016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors