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Study to Determine the Safety and Efficacy of Tanovia™ (Rabacfosadine for Injection) in Cats with Lymphoma, Lymphoid Leukemia, Multiple Myeloma, or Plasma Cell Tumor; Using a Dose Escalation Model.

Aug 03, 2018

STUDY OBJECTIVE

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. Cats must have adequate organ function as indicated by standard laboratory tests: (hematology [CBC], clinical chemistry [CC] and urinalysis [UA]). Specifically, cats must have:

  • Absolute neutrophil count > 1,500 cells/μL
  • Hematocrit > 25%
  • Platelet count > 100,000/μL
  • Serum creatinine < 2.5 mg/dL
  • Bilirubin ≤ the upper normal limit
  • Transaminases ≤ 3 times the upper normal limit or if > 3
  • times the upper normal limit then serum bile acids must
  • be ≤ the upper normal limit
  • The animal must have a performance status of < 1 on
  • Day 0, according to the modified ECOG Performance
  • Scheme (Veterinary and Comparative Oncology, 2010).
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.