GI Microbiome in Dogs Receiving Palladia™
Monitoring of the gastrointestinal microbiome in dogs receiving toceranib phosphate (Palladia™) therapy
Purpose & Explanation of Study:
The primary purpose of this study is to monitor the gastrointestinal tract microbiome of dogs receiving toceranib phosphate therapy in the hope that modification of the gastrointestinal environment with probiotics may provide dogs with clinical benefit.
Toceranib phosphate (Palladia™) was the first veterinary anti-cancer agent to obtain FDA approval based on demonstrable safety and efficacy in the treatment of canine mast cell tumors. Toceranib has subsequently demonstrated benefit in the treatment of numerous canine malignancies. Toceranib has direct anti-cancer, as well as anti-angiogenic activity, and recent research suggests a role in immune system modulation. Unfortunately, like most anti-cancer agents, toceranib does have side effects. The most common side effect that results in dosing modifications, and the prescription of additional medications, is diarrhea.
What does enrollment into into this trial involve?
Dogs that have been diagnosed with a malignant tumor and have not been previously treated with either toceranib are eligible for this study. All dogs will receive toceranib administered by mouth every other day for the duration of the study. Blood, urine and fecal samples will be collected at baseline, two weeks after commencing toceranib therapy, and then monthly. After study day 168 (or sooner if your dog is removed from this study for any reason), the study will be completed and the oncology clinician will discuss additional and/or ongoing treatment options with you as the dog’s owner and primary care giver.
Any dog with a confirmed malignant tumor that has not been previously treated with toceranib (Palladia™), and is a good candidate for Palladia™ treatment for their current tumor.
This study covers only the cost of fecal sampling and analysis. The owner is responsible for all other fees.
For more information, please contact Misty Bear, Clinical Trials Coordinator:
Phone: (785)532-3046; E-mail: ClinicalTrials@vet.k-state.edu