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Study to Determine the Safety and Efficacy of TANOVEA™ (Rabacfosadine for Injection) in Cats with Lymphoma, Lymphoid Leukemia or Multiple Myeloma/Plasma Cell Tumor

Jun 04, 2019

The primary objective of this study is to determine the maximum tolerated dose, dose-limiting toxicities, safe starting dose, and pharmacodynamic effect of TANOVEA™ (rabacfosadine for injection) in cats with lymphoma, lymphoid leukemia or multiple myeloma/plasma cell tumor.

A secondary objective of this study is to assess the efficacy and determine progression-free survival in treated cats.

Inclusion criteria:

  • Species: Feline
  • Breed: No specification
  • Initial age: At least 1 year old on Day 0
  • Weight: No weight requirement
  • Sex: Male or female, intact or neutered
  • Origin: Client–owned cats

Diagnosis:

Cats must have a diagnosis of low, intermediate or high grade, lymphocytic or lymphoblastic lymphoma, cytologically or histologically confirmed in any anatomic site.

Prior treatment:

Prior surgery, radiotherapy, and/or chemotherapy are acceptable. There must be a two-week washout period between prior chemotherapy and Day 0 and a six-week washout period between radiotherapy and Day 0.

General health: Cats must be free of severe underlying disease (including underlying pulmonary pathology), be FeLV, and FIV negative, and have an expected survival of at least 6 weeks.

Exclusion criteria:

  • Cats that have received chemotherapy within 2 weeks of Day 0.
  • Cats that have received non-steroidal anti-inflammatory drugs (NSAIDS) within 72 hours of Day 0. While on study, treatment with prednisone (1 mg/kg every other day) is acceptable.
  • Cats that have received radiation therapy within 6 weeks of Day 0.
  • Concurrent malignancy or other serious systemic disorder incompatible with this study.

Owner Incentives:

  • TANOVEA™ (Rabacfosadine for Injection) is provided at no cost for use in this study.
  • $1,500 client incentive for each cat enrolled, to be used for treatment costs.
  • In the event of AE-related hospitalization costs as a result of participation in the study, up to $3,000 per cat to cover clinical trial-related hospitalization costs. This will be addressed on a case-by-case basis.
  • Client is responsible for all other charges.

Contact:

Michelle Morges, DVM, MS, DACVIM (Oncology), cVMA
Medical Oncology and Acupuncture

Red Bank Veterinary Hospital
197 Hance Ave, Tinton Falls, NJ 07724
(732) 747-3636

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