A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Time to Reach Maximum Observed Plasma Concentration (Tmax)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Advanced cancer potentially sensitive to vinorelbine:
- •Breast cancer.
- •Stage 3 or 4 non-small cell lung cancer.
- •Non-Hodgkins lymphoma.
- •Cancer of other histologic type, sensitive to vinca alkaloids.
- •Rare tumor type with no standard treatment, for which single agent vinorelbine is appropriate therapy.
- •Failure of standard treatment(s) of the tumor.
- •Life expectancy of at least three months.
- •ECOG performance level 0-2 or Karnofsky score 100-
- •Hematological and serum chemistry results with defined ranges.
- •Willingness and ability to provide written informed consent.
排除标准
- •Pregnancy or lactation. In a woman of childbearing potential, a positive pregnancy test result, no pregnancy test result, or no use of reliable contraception, at baseline. A postmenopausal woman will be considered to be of childbearing potential until there has been amenorrhea for at least 12 consecutive months.
- •Previous treatment with vinorelbine or mitomycin.
- •Any history suggesting or demonstrating resistance to, lack of response to, or intolerance of any prior vinca alkaloid treatment.
- •Active infection.
- •Prior anticancer therapy completed within four weeks prior to the first day of study treatment.
- •Failure to have recovered from any toxicity of previous cancer treatment (patients with alopecia will not be excluded).
- •Participation in another experimental drug study within four weeks prior to the first day of study treatment.
- •Requirement for any concomitant chemotherapeutic agent other than the study medication.
- •Any investigator judgment that the individual would not be an appropriate study subject.
结局指标
主要结局
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0-144 hours post dose
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0-144 hours post-dose
Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
时间窗: 0-144 hours post-dose
Determined Using the Linear Trapezoidal Rule
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
时间窗: 0-144 hours post-dose
AUCinf = AUClast + (Clast/lamda z)
Percentage of AUCinf Based on Extrapolation (AUCextrap)
时间窗: 0-144 hours post-dose
Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)
时间窗: 0-144 hours post-dose
Estimated via linear regression of the time versus log concentration
Observed Terminal Elimination Half-Life (t1/2)
时间窗: 0-144 hours post-dose
t1/2 = \[ln(2)/λ z\]
Time of Last Measurable Concentration (Tlast)
时间窗: 0-144 hours post-dose
Last Quantifiable Drug Concentration (Clast)
时间窗: 0-144 hours post-dose
Mean Residence Time (MRTinf)
时间窗: 0-144 hours post-dose
MRT = (AUMCinf)/(AUCinf)
次要结局
未报告次要终点