Double-Blinded Study to Compare Efficacy and Safety of Masitinib to Placebo in the Treatment of Grade II and III Non-Resectable Mast Cell Tumors in Dogs
Mast cell tumors (MCT) in dogs are very common, accounting for approximately 20% of all skin tumors in dogs. They can arise from any skin site on the body, and while they often appear small and somewhat insignificant, they can be a very serious form of cancer in the dog. Some MCT’s are easily removed without development of further problems; however, others may lead to a life-threatening disease if not properly identified and treated.
The purpose of this study is to evaluate the efficacy and safety of masitinib in comparison to placebo in dogs with grade 2-3 non-resectable mast cell tumors, not previously treated by chemotherapy (other than corticosteroids) or radiotherapy. Masitinib is a tyrosine kinase inhibitor (TKI) that has been shown to improve long-term survival of dogs with non-resectable tumors.
- Dogs with a histological or cytological confirmation of cutaneous/subcutaneous MCT, Grade II or III (+/- lymph node involvement), where surgical excision is not feasible or has been declined will be treated.
- Adequate renal, hepatic and hematologic parameters.
- Patient must be > 1 year of age and must weigh > 6.9 kg
- MCT must be > 10mm, longest diameter (15 mm for lymph nodes) and accessible for biopsy
- Free clinical staging; CBC, chemistry, urinalysis, fine needle aspirate of regional lymph node, +/- bone marrow aspirate (only if + node), abdominal ultrasound, thoracic
radiographs, and tumor biopsy.
- Free study medications (masitinib or placebo)
- Free recheck exams
- A total value of up to ~$9000, without the support of this clinical trial!
Clinical Studies Core
Phone: 919-515-2633 or 919-513-6384; Fax: 919-513-6680
Page last updated August 08, 2014