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A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.

Phase 1
18 Years
Not Enrolling
Breast Cancer, Non-small Cell Lung Cancer, Non-Hodgkins Lymphoma

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Trial Information

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.

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

- 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

- Any investigator judgment that the individual would not be an appropriate study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Outcome Time Frame:

0-144 hours post dose

Safety Issue:


Principal Investigator

Lino Arboit, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fundación Centro Oncológico de Integración Regional - COIR.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Non-Hodgkins Lymphoma
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin