Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Status: administratively complete

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

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 these kinase targets, masitinib is also thought to promote

survival via modulation of immunostimulation-mediated anticancer effects and modulation

of the tumor microenvironment. The objective of this prospective, multicenter,

randomized, open-label, active-controlled study is to compare the efficacy and safety of

masitinib with respect to imatinib in the first line treatment of gastro-intestinal

stromal tumor (GIST). Treatment will be given until disease progression, limiting

toxicity or patient consent withdrawal.

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