Preclinical Assessment of an oral p97 inhibitor, CB-5339, in Tumor-Bearing Dogs

Patient Disease:

Canine Neoplasia

Study Name:

COTC028: Preclinical Assessment of an oral p97 inhibitor, CB-5339, in Tumor-Bearing Dogs

Purpose of the study:

  • To establish the safety, tolerability, and maximally tolerated dose of oral CB-5339 when administered daily for 4 days a week for 2 weeks, with one week off, to dogs with various types of cancer

Primary Eligibility Criteria:

  • Dogs with a diagnosis of any tumor type except mast cell tumor or hemangiosarcoma with a minimum tumor size of 3 cm

  • Weight ≥ 15 kg

  • Two-week washout from chemotherapy or radiation therapy; 7-day washout from L-asparaginase or corticosteroids in dogs with lymphoma

Study Protocol:

  • Prior to starting treatment, dogs will have a tumor biopsy and bone marrow aspirate performed for study purposes

  • Study drug will be given orally in 21-day cycles: 4 days per week for two weeks and one week off

  • After the first dose of treatment, dogs will need to stay in the hospital for the day for serial blood collections and tumor biopsies, and return the following day for blood collection and tumor biopsy

  • Recheck visits will be required on Days 8, 15, and 22 of the study for a physical exam and blood collection; a tumor biopsy will also be done on Day 8

  • If the dog is responding to treatment, he or she can continue on the study for additional treatment cycles

Owner Responsibilities:

  • You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist

  • You are expected to make and keep all appointments associated with the study

Financial Incentives:

  • Once enrolled, all costs associated with this study will be provided as part of participation

  • Owners will also be reimbursed for the costs of the pre-enrollment physical exam, chest x-rays, and abdominal ultrasound (if needed)

  • In the event any complications arise from CB-5339 administration, their management will be covered by study funds up to $1000/per dog

  • Owners will receive a $1000 credit to their pet’s VTH account to put towards further treatment at the time of withdrawal from the study

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