CONNECTICUT
Study: A novel form of antiangiogenic therapy in dogs with measurable soft tissue sarcoma.

Contact: Veterinary Oncology & Hematology Center, Norwalk CT (203-838-6626)

Summary: An estimated 86 client-owned pet dogs will be enrolled in this Phase II study. The study is a randomized,
investigator-masked, placebo-controlled study in dogs with measurable soft tissue sarcoma. The randomization of active
Test Article to placebo will be 1:1 with a crossover option for dogs in the placebo arm that have disease progression.
The first eight (8) dogs enrolled in the study will be assigned to receive active Test Article in an open label manner and
will have blood samples collected over a period of 24 hours post treatment. Once enrolled, study patients will be
evaluated at Days 14, 28 and every 28 days thereafter until tumor progression occurs.

Eligibility:
  • Histologic diagnosis or grade II or III soft tissue sarcoma
  • At least one measurable soft tissue sarcoma between 1-7cm diameter
  • Generally feeling well
  • No evidence of an active infection requiring antibiotics within 7 days of enrollment
  • No anti-cancer therapy within 21 days of enrollment, including chemotherapy, radiation therapy, corticosteroids,
    and immunotherapy
  • No tumors located in regions where abscess would result in major symptoms

Exclusion:
  • Anticipated poor owner compliance
  • Dogs that have received anti-cancer therapy of any type (e.g. chemotherapy, radiation therapy, immunotherapy)
    within 3 weeks prior to study treatment start
  • Dogs that have a concurrent medical disorder likely to result in death or euthanasia within 1 month or a condition
    that may be disruptive to the intent and objectives of the study
  • Dogs that are pregnant or likely to become pregnant
  • Dogs that are participating in another study
  • Dogs that may be unavailable for the full duration of the trail or that is felt to be unsuitable by the investigator for
    any other reason

Financial Incentive: This trial is fully funded. The study sponsor will pay for the costs of diagnostic tests required for
enrollment into the study (bloodwork, X-rays, abdominal ultrasound), the study treatments, follow up evaluations
including examinations and diagnostic tests, and management of side effects that are the result of treatment with the
compound.
PET CANCER CENTER
Comprehensive guide to cancer diagnosis and treatment in cats and dogs
© 2007 Pet Cancer Center. ALL RIGHTS RESERVED.
Last updated 8/16/13
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