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.

Sponsor:

Information provided by (Responsible Party):

AB Science

ClinicalTrials.gov Identifier:

NCT00998751

First received: October 19, 2009

Last updated: September 19, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 19, 2009
Last Updated Date	September 19, 2012
Start Date ^ICMJE	June 2005
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 19, 2009)	Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00998751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 19, 2009)	Progression Free Survival [ Time Frame: until disease progression ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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)
Official Title ^ICMJE	Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Gastro-intestinal Stromal Tumours
Intervention ^ICMJE	Drug: oral masitinib 7.5 mg/kg/day Other Name: AB1010
Study Arm (s)	Experimental: masitinib (AB1010) oral masitinib 7.5 mg/kg/day Intervention: Drug: oral masitinib
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	June 2014
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00998751
Other Study ID Numbers ^ICMJE	AB04016
Has Data Monitoring Committee	No
Responsible Party	AB Science
Study Sponsor ^ICMJE	AB Science
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AB Science
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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