Safety, tolerability and pharmacokinetic properties of the novel triazene TriN 2755 in tumour bearing dogs - a phase I study.
Vet Comp Oncol
; 15(1): 94-104, 2017 Mar.
Article
in En
| MEDLINE
| ID: mdl-25689225
ABSTRACT
TriN 2755 is an alkylating antineoplastic agent for intravenous (IV) use, carrying the triazene group as the cytotoxic principal. Using a standard 3 + 3 design, a phase I study was performed in tumour bearing dogs to determine the maximum tolerated dose (MTD), the dose limiting toxicity (DLT), and pharmacokinetic (PK) profile of TriN 2755. Thirty dogs were included in the study. TriN 2755 was administered over 20 min on two consecutive weeks per month for a total of three cycles. The starting dose was 25 mg kg-1 and the MTD was 74.6 mg kg-1 . Three dogs experienced DLT, which was characterized by gastrointestinal adverse events. The PKs of TriN 2755 and its main metabolites in plasma and sputum are described in a two-compartment model. The response rate for 19 of 30 dogs was 47.3% (six partial remission, three stable disease) and the median progression-free interval (PFI) for the responders was 47 days (range 21-450 days).
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Triazenes
/
Dog Diseases
/
Neoplasms
/
Antineoplastic Agents
Type of study:
Diagnostic_studies
/
Prognostic_studies
Limits:
Animals
Country/Region as subject:
Europa
Language:
En
Journal:
Vet Comp Oncol
Journal subject:
MEDICINA VETERINARIA
/
NEOPLASIAS
Year:
2017
Document type:
Article
Affiliation country:
Suiza