A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment
GISTs are uncommon visceral sarcomas that arise predominantly in the gastrointestinal tract.
Most GIST cells are positive for c-kit (CD117), a cell surface antigen corresponding to the
Stem Cell Factor (SCF) receptor. The receptor has an intracellular tyrosine kinase (TK)
joined by a juxtamembrane domain. It is hypothesized that all malignant GIST cells harbor a
mutation of c-kit, resulting in the activation of c-kit and cell division and tumour growth.
Drugs that can selectively inhibit TKs are likely to be of benefit in GISTs. Masitinib
(AB1010) is a TK inhibitor, selectively and effectively inhibiting c-kit. Imatinib is also a
TK inhibitor indicated in the treatment of GIST. It might be associated with side effects
and patients might develop a resistance to treatment over time. Based on pre-clinical and
clinical studies, masitinib (AB1010) can be considered as a good candidate in the second
line treatment of patients with GIST after progression with imatinib.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death
up to 24 weeks
No
United States: Food and Drug Administration
AB11002
NCT01694277
September 2012
December 2015
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