Phase II Open-label Non-randomized Multicenter Clinical Trial of Trametinib for Dogs With Histiocytic Sarcoma

The University of Florida College of Veterinary Medicine is currently recruiting dogs diagnosed with Histiocytic Sarcoma for a clinical research trial.

Enrollment Criteria: Currently Enrolling

• Inclusion Criteria: Your dog has been diagnosed with Histiocytic Sarcoma
• Treatment: Prior to treatment with the study drug (trametinib), a tumor biopsy, and a blood sample (less than one ounce) will be collected. A tumor biopsy will be taken only when tumors are accessible, via a small incision through the skin, and collection of a small piece of tumor tissue, with the patient under sedation. Enrolled dogs will have a physical examination, laboratory analysis, blood pressure measurement, and diagnostic imaging (x-rays and ultrasound). Trametinib will be given by mouth, once daily, as long as your dog is responding to treatment

• Cost: This study will cover the costs of the Trametinib medication, recheck physical examination fees, collection of blood and tumor samples for investigation, and routine laboratory tests/diagnostic imaging (thoracic radiographs and abdominal ultrasound) at scheduled recheck study visits.
• Cost: This study will cover the costs of the Trametinib medication, recheck physical examination fees, collection of blood and tumor samples for investigation, and routine laboratory tests/diagnostic imaging (thoracic radiographs and abdominal ultrasound) at scheduled recheck study visits.
• Contact: Please complete the Study Interest Form for more information.
• PI: Dr. Marilia Takada and Dr. Paulo Vilar Saavedra

Background: The purpose of this research is to investigate a new anti-cancer drug, trametinib, that specifically ‘targets’ growth signals found in cancer cells from companion (pet) dogs. This study will determine the anti-tumor efficacy of trametinib in dogs with histiocytic sarcoma. We will measure and document how much the cancer shrinks upon treatment, and how the drug helps improve the patients’ outcome and life expectancy. Additionally, the study will test whether markers in the genes within the tumor can predict the response from treatment, which in the future can help select those dogs that are more likely to respond positively to treatment. Finally, in a simple blood test we will determine whether effective drug levels are present in the patient.