Safety of masitinib mesylate in healthy cats.
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BACKGROUND: Masitinib mesylate is a PO-administered tyrosine kinase inhibitor developed both for human and animal diseases with activity against both mutated and wild type forms of the c-kit receptor and platelet-derived growth factor receptors and , and is currently registered in Europe for the treatment of mast cell tumors in dogs. HYPOTHESIS/OBJECTIVES: The objective of this study was to determine if healthy cats can tolerate administration of masitinib without clinically relevant adverse effects. ANIMALS: Twenty healthy research colony-specific pathogen-free cats. METHODS: This study was a prospective, randomized phase 1 clinical trial. Masitinib was administered PO to 20 healthy cats. Ten cats received 50 mg masitinib every other day for 4 weeks, and 10 cats received 50 mg masitinib daily for 4 weeks. RESULTS: Clinically relevant proteinuria was noted in 2/20 (10%) cats (both treated daily), and neutropenia was noted in 3/20 (15%) (seen in both treatment groups). An increase in serum creatinine concentration and adverse gastrointestinal effects were noted in some cats. CONCLUSIONS AND CLINICAL IMPORTANCE: Masitinib mesylate was tolerated in the majority of cats. Long-term administration and pharmacokinetic studies are needed to further assess the use of masitinib in cats.