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: Dogs with a cytological or histological diagnosis of Histiocytic Sarcoma with a measurable tumor, and who have a life expectancy of at least 4 weeks.
  • 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. Your dog will need to return 2 weeks after the starts, and then every 4 weeks for evaluation and diagnostics tests, until week 14.
  • 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. As a reminder, all patients must first be evaluated by our Oncology Service via referral.
  • PI: Dr. Marilia Takada

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. Trametinib is FDA approved for use in people, and our previous studies have identified the safe dose for 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.

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