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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by AB Science.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
AB Science 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
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 ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: until disease progression ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00998751

Villejuif, France
Sponsors and Collaborators
AB Science
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AB Science Identifier: NCT00998751     History of Changes
Other Study ID Numbers: AB04016
Study First Received: October 19, 2009
Last Updated: September 19, 2012

Keywords provided by AB Science:
cKIT inhibitor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases processed this record on May 25, 2017