The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the
treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma
carrying a mutation in the juxta membrane domain of c-Kit and who have not previously
been treated for melanoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01280565.
Masitinib is a selective tyrosine kinase inhibitor with potent activity against the juxta
membrane domain of c-Kit. Masitinib is also thought to promote survival via modulation of
immunostimulation-mediated anticancer effects and modulation of the tumor
microenvironment. The objective of this study was to evaluate the efficacy and safety of
masitinib with respect to dacarbazine in the treatment of non-resectable or metastatic
stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit.
Following a protocol amendment, the dacarbarzine treatment group was closed and
recruitment restricted to masitinib treatment of chemo-naïve (first-line) patients.
Lead OrganizationAB Science