Focal Adhesion Kinase (FAK) Inhibition to Improve Losartan-Toceranib Immunotherapy in Canine Metastatic Osteosarcoma

Patient Disease:

Canine Osteosarcoma with Metastasis to the Lungs

Study Name:

Focal Adhesion Kinase (FAK) Inhibition to Improve Losartan-Toceranib Immunotherapy in Canine Metastatic Osteosarcoma

Purpose of the study:

  • To determine whether the 3-drug combination of Palladia, losartan, and defactinib can give better cancer control in dogs with metastatic osteosarcoma (OS) than the original 2-drug combination (Palladia/losartan)
  • A secondary goal of this study is to assess gene expression in a type of immune cell called macrophages present in the lungs of dogs with metastatic OS; this will be accomplished through a procedure called bronchoalveolar lavage (BAL)

Primary Eligibility Criteria:

  • Dogs with a confirmed diagnosis of osteosarcoma via surgery to remove their primary tumor with measurable metastatic disease in the lungs visible on chest X-rays
  • At least 1 year old; minimum weight 10 kg (22 lb)
  • Adequate blood work
  • Two week washout from any anti-cancer therapy
  • No prior treatment for lung metastasis
  • No metastatic disease anywhere besides the lungs
  • Pets must come to CSU for all visits related to the clinical trial

Study Protocol:

  • Dogs will be treated with oral losartan (twice daily), oral defactinib (once daily) and oral Palladia (once every other day)
  • Serial blood samples will be collected in hospital for 8 hours after the first dose of defactinib
  • Rechecks will be required 2 and 4 weeks after starting treatment and every 4 weeks thereafter if tumors are stable or better
  • Chest x-rays will be rechecked every 4 weeks while on study
  • BAL will be performed prior to starting the study and at the Week 8 visit

Owner Responsibilities:

  • You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist
  • You will also be responsible for the costs of all exam fees, diagnostics (blood and urine tests, blood pressure monitoring, and chest x-rays), and any additional medications that are prescribed throughout the duration of the study beyond the $750 study incentive
  • You are expected to make and keep all appointments associated with the study
  • You must be comfortable administering oral medications at home

Financial Incentives:

  • Toceranib, losartan, and defactinib will be provided at no cost other than the pharmacy dispensing fee ($8 per prescription)
  • $750 will be applied to your pet’s account to go towards the costs of study-related exams, diagnostics, and medications
  • All costs associated with both bronchoalveolar lavage procedures (including anesthesia) and all study blood collections will be covered by the study
  • Up to $500 is available to treat side effects related to the study drugs

If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.

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