A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.
ANX-530 (vinorelbine tartrate injectable emulsion), an investigational drug, is an
oil-in-water emulsion of vinorelbine tartrate composed of an oil phase and emulsifier
dispersed in an aqueous solution. ADVENTRX Pharmaceuticals, Inc. of San Diego, California,
developed ANX-530 as a vinorelbine tartrate formulation to be used in clinical settings
where Vinorelbine Tartrate Injection (NAVELBINE) is indicated. Nonclinical toxicology
studies suggest either equivalent or less toxicity of ANX-530 compared to Reference Product.
In particular, ANX-530 caused less vein toxicity in a rabbit vein irritation model,
suggesting ANX-530 could potentially cause less venous irritation than NAVELBINE in a
clinical setting. ADVENTRX is investigating whether ANX-530 could substitute for NAVELBINE
in these settings.
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0-144 hours post dose
Lino Arboit, M.D.
Fundación Centro Oncológico de Integración Regional - COIR.
United States: Food and Drug Administration