Study to Determine the Safety and Efficacy of TANOVEA™ (Rabacfosadine for Injection) in Cats with Lymphoma, Lymphoid Leukemia, Multiple Myeloma, or Plasma Cell Tumor; Using a Dose Escalation Model.
Aug 03, 2018
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.
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).
- 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.
- 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.