A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
First received: October 19, 2009
Last updated: September 19, 2012
Last verified: September 2012

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.

Condition Intervention Phase
Gastro-intestinal Stromal Tumours
Drug: oral masitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

Resource links provided by NLM:

Further study details as provided by AB Science:

Primary Outcome Measures:
  • Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: until disease progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2005
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: masitinib (AB1010)
oral masitinib 7.5 mg/kg/day
Drug: oral masitinib
7.5 mg/kg/day
Other Name: AB1010


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998751

Villejuif, France
Sponsors and Collaborators
AB Science
  More Information

No publications provided by AB Science

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00998751     History of Changes
Other Study ID Numbers: AB04016
Study First Received: October 19, 2009
Last Updated: September 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AB Science:
cKIT inhibitor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 23, 2014