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The purpose of this initial pilot pharmacokinetic study is to confirm the prolonged plasma exposure of STA-12-4049 in dogs with cancer prior to performing a larger study that would evaluate the biologic activity of Elesclomol in dogs with cancer.
Elesclomol is a novel anticancer agent that works primarily by binding copper (Cu) and subsequently inducing cell death. Briefly, Elesclomol binds Cu in the plasma then the Elesclomol-Cu complex (STA-12-4049) then enters the cell where it absorbs electrons and induces cell death secondary to oxidative stress. Elesclomol had limited activity in human clinical trials and subsequent work indicated that tumor cell death is related to the exposure time to Elesclomol. As such, there may be a potential benefit to sustained exposure (i.e., longer infusion) of Elesclomol. Interestingly, in dogs, STA-12-4049 levels are much higher for longer periods of time following Elesclomol infusion compared to humans. This suggests that dogs may be a good model in which to evaluate the potential biologic activity associated with prolonged STA-12-4049 blood levels. Prior work in healthy laboratory dogs indicates that Elesclomol is very well tolerated, with the NOAEL of 25 mg/kg once per week. Therefore, it is expected that a dose of 3 mg/kg will not be associated with any significant adverse events. The purpose of this study is to determine the range of plasma levels of STA-12-4049 in dogs with cancer following Elesclomol administration prior to performing a larger clinical trial of Elesclomol in dogs with cancer. The specific aims are to assess the pharmacokinetics of Elesclomol in dogs with cancer after a single 1 hour infusion and to assess the clinical toxicities associated with Elesclomol after a single 1 hour infusion.
To qualify for enrollment in this study, dogs must:
This clinical trial involves the collection of blood samples from dogs during and following a 1 hr infusion of Elesclomol. Blood samples will be taken at 0, 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post infusion. All samples except the 0.5 hr sample will be taken from an indwelling catheter. Approximately 2 ml of blood will be taken at each time point for plasma collection. The total amount of blood taken will be approximately 18 mls (4 tsp.). Dogs will then be sent home the following day.
The sponsor will cover study associated costs for screening, exam fees and lab work. The sponsor will also credit to the patient’s account $500 to be used towards further cancer treatment at The Ohio State Veterinary Medical Center.
Please contact the Clinical Trials Office at the Veterinary Medical Center for more information about this study.