Status:
COMPLETED
Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
Lead Sponsor:
AB Science
Conditions:
Gastro-intestinal Stromal Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Documented allergy to the similar drug of AB1010
- Inadequate organ function
- Patients with a history of any other malignancy
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00998751
Start Date
June 1 2005
End Date
June 1 2013
Last Update
December 11 2018
Active Locations (1)
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1
Lecesne
Villejuif, France