Masitinib in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by AB Science. Recruitment status was Active, not recruiting

First Received on October 19, 2009. Last Updated on October 20, 2009 History of Changes

Sponsor:	AB Science
Information provided by:	AB Science
ClinicalTrials.gov Identifier:	NCT00998751

Purpose

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:	January 2011
Estimated Primary Completion Date:	January 2011 (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

Eligibility

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

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

Contacts and Locations

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

Locations

France
Lecesne
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):

Le Cesne A, Blay JY, Bui BN, Bouché O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naïve patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. Epub 2010 Mar 6.

Responsible Party:	AB Science
ClinicalTrials.gov Identifier:	NCT00998751 History of Changes
Other Study ID Numbers:	AB04016
Study First Received:	October 19, 2009
Last Updated:	October 20, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by AB Science:

cKIT inhibitor
GIST

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 15, 2012