Status:
TERMINATED
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Lead Sponsor:
AB Science
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Detailed Description
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against thes...
Eligibility Criteria
Inclusion
- Main inclusion criteria include:
- Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST
- Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
- c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative
- Main exclusion criteria include:
- Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria
- Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
- Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT00812240
Start Date
January 1 2009
End Date
July 1 2018
Last Update
February 1 2023
Active Locations (41)
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1
MD Anderson Cancer Center
Orlando, Florida, United States, 32806
2
The Emory Clinic
Atlanta, Georgia, United States, 30322
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
Beth Israel Medical Center
New York, New York, United States, 10003