The objective of this study is to assess the pain management effect and safety of a novel combination of compounds dogs with appendicular (front legs or back legs) osteosarcoma. The study involves the pet owners administering the investigational compounds as 3 times weekly subcutaneous injections, for a total of 4 weeks. There is no placebo group in this study.
Trained veterinarians at the trial sites will evaluate each dog for eligibility based on the following criteria:
- The dog has a cytological or histopathological diagnosis of osteosarcoma (high suspicion of OSA on radiographs may also be accepted)
- Dog has gross appendicular OSA.
- The dog is at least 1 year old.
- The dog weighs more than 11 pounds.
- The dog is feeling reasonably well other than the discomfort associated with the cancer.
- The dog has a minimum pain index based on interpretation by the study veterinarian and in communication with the owner.
- Prior glucocorticoid therapy, chemotherapy, bisphosphonates, radiation therapy or small molecule inhibitor therapy is acceptable following a 21-day washout.
- Prior immunotherapy or targeted monoclonal antibody therapy is acceptable following a 42-day washout.
- Prior use of NSAIDs are permitted granted the dog has been receiving the current regimen for at least 14 days prior to enrollment. Further, ongoing treatment should maintain the same dosage and treatment schedule as use prior to enrollment.
- No other major medical problems.
*Other study criteria may apply. The veterinary investigator will determine eligibility at the time of consultation.*
If dogs are enrolled, the following funding is provided:
- Full for the diagnostic tests and procedures required by the study
- Metabolic therapy, including administration costs
- Side effects if attributable to the metabolic therapy
- $1,000 incentive upon completion of the 4-week study and associated owner assessments