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

Phase 2

Completed

• Conditions: Gastro-intestinal Stromal Tumours
• Interventions: Drug: oral masitinib

• Registration Number: NCT00998751
• Lead Sponsor: AB Science

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-08
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
masitinib (AB1010)	oral masitinib	oral masitinib 7.5 mg/kg/day

Primary Outcome Measures

Name	Time	Method
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)	2 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	until disease progression

Trial Locations

Locations (1)

Lecesne; 🇫🇷 Villejuif, France