This study was a randomized, single dose crossover comparison of the investigational product with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective was to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Subjects received one dose each of ANX-530 and NAVELBINE, each providing 30 mg/m2 vinorelbine. Study drugs will be infused into an arm vein over ten minutes.
Clinical Investigative Site
Buenos Aires, Argentina
Clinical Investigative Site
Mendoza, Argentina
Clinical Investigative Site
Rosario, Argentina
Clinical Investigative Site
San Miguel de Tucumán, Argentina
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-144 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-144 hours post-dose
Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Determined Using the Linear Trapezoidal Rule
Time frame: 0-144 hours post-dose
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
AUCinf = AUClast + (Clast/lamda z)
Time frame: 0-144 hours post-dose
Percentage of AUCinf Based on Extrapolation (AUCextrap)
Time frame: 0-144 hours post-dose
Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)
Estimated via linear regression of the time versus log concentration
Time frame: 0-144 hours post-dose
Observed Terminal Elimination Half-Life (t1/2)
t1/2 = \[ln(2)/λ z\]
Time frame: 0-144 hours post-dose
Time of Last Measurable Concentration (Tlast)
Time frame: 0-144 hours post-dose
Last Quantifiable Drug Concentration (Clast)
Time frame: 0-144 hours post-dose
Mean Residence Time (MRTinf)
MRT = (AUMCinf)/(AUCinf)
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Clinical Investigative Site
Santa Fe, Argentina
Time frame: 0-144 hours post-dose