Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
NCT ID: NCT00998751
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2005-06-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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masitinib (AB1010)
oral masitinib 7.5 mg/kg/day
oral masitinib
7.5 mg/kg/day
Interventions
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oral masitinib
7.5 mg/kg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Inadequate organ function
* Patients with a history of any other malignancy
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Locations
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Lecesne
Villejuif, , France
Countries
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References
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Le Cesne A, Blay JY, Bui BN, Bouche 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-naive patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6.
Other Identifiers
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AB04016
Identifier Type: -
Identifier Source: org_study_id