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.

Inclusion Criteria:

• 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 100-70.
• Hematological and serum chemistry results with defined ranges.
• Willingness and ability to provide written informed consent.

Exclusion Criteria:

• 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.