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CSU Animal Cancer Center Clinical Trial

Patient Disease:
Canine Mast Cell Tumor

Study Name:
Correlation of circulating plasma levels of cytokeratin 18 (CK18) with diarrhea in dogs with mast cell tumor treated with toceranib phosphate (Palladia)

Purpose of the study:

  • CK18 is expressed in epithelial cells of the gastrointestinal tract
  • During cell death fragments are released into the bloodstream and can be utilized as a biomarker
  • Dogs treated with toceranib (Palladia) that have adverse events, most commonly have gastrointestinal signs
  • This study evaluates the use of this CK18 as a biomarker to predict gastrointestinal toxicity in dogs with mast cell tumors treated with Palladia

Primary Eligibility Criteria:

  • Dogs diagnosed with cutaneous or subcutaneous mast cell tumors
  • Must have had the tumor surgically removed and have no evidence of recurrence or metastasis
  • Dogs must be in good health otherwise, with relatively normal lab work (complete blood count, chemistry profile, urinalysis, urine protein test),  and normal blood pressure
  • Dogs must not have gastrointestinal symptoms
  • There must be a one week washout from chemotherapy or radiation therapy

Study Protocol:

  • Pre-enrollment: Physical exam, lab work (complete blood count, chemistry profile, urine testing), blood pressure measurement, biopsy to confirm mast cell tumor and eligibility for the clinical trial
  • Day 0: Start treatment, fill in daily log
  • Weekly visits until day 28 for  physical exams, lab work, urine testing, blood pressure, and toxicity assessments
  • If the dog is doing well, and the owner wishes to continue treatment, they will be given 3 additional months of Palladia at no cost

Owner Responsibilities:

  • The cost of the initial diagnostics to confirm eligibility for enrollment, the exam fees, and diagnostics related to Palladia treatment.
  • The owner must  also fill out a daily log to document Palladia administration and side effects
  • The owner is expected to make and keep appointments according to the clinical trial protocol

Financial Incentives:

  • The study will cover the cost of Palladia for the duration of the study (4 weeks) and then for an additional 3 months if this treatment is continued

If you have further questions about any of our clinical trials, Please either login or sign up to submit a consulting form. Your consult will then be directed to an appropriate oncology clinician. Requests are typically returned within 5 business days