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

Sponsor: AB Science
Study ID: NCT00998751
Phase: PHASE2
Status: Completed

Conditions

Gastro-intestinal Stromal Tumours

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

oral masitinib — DRUG
7.5 mg/kg/day

Study Details

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.

Key Dates

Start date: Jun 30, 2005
Status verified: Dec 2018
Primary completion: Jun 30, 2013
Completion: Jun 30, 2013

Study Design

Enrollment: 30 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: masitinib (AB1010)
oral masitinib 7.5 mg/kg/day

Primary Outcome Measure

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