Table 1. Adverse events occurring in dogs in the phase I escalation study of EC0531.
Dose of EC0531 | Number of dogs receiving that dose | Number of doses given | Adverse events defined by VCOG-CTCAE (G–Grade; DLT–Dose limiting toxicity) |
---|---|---|---|
0.18 | 1 | 6 | 1 dog with G1 anorexia |
0.20 | 4 | 14 | 1 dog with G2 anorexia |
0.22 | 4 | 10 | 1 dog with G1 lethargy |
0.24 | 4 | 16 | 1 dog with G2 neutropenia |
0.26 | 6 | 33 | 1 dog with G1 lethargy 1 dog with G1 vomiting and G1 neutropenia 1 dog with G2 neutropenia 1 dog with G3 neutropenia (DLT) and G2 diarrhea |
0.28 | 10a,b | 63 | 1 dog with G1 vomitinga 1 dog with G1lethargy and G3 weight loss (DLT)a 1 dog with G4 neutropenia (DLT)b 1 dog with G4 infusion reaction (DLT)b |
0.30 | 2 | 15 | 1 dog with G3 neutropenia (DLT) |
0.32 | 1 | 2 | No adverse events observed |
0.34 | 1 | 5 | 1 dog with G3 anorexia (DLT) |
aFour dogs initially received a lower dose of EC0531, and then underwent intra-patient dose escalation to receive 0.28 mg/kg EC0531.
bSix new dogs were enrolled for which their initial dose of EC0531 was 0.28 mg/kg.