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Completed

NCT Number: NCT00432562

A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non-Hodgkins Lymphoma Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Investigative Site, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vinorelbine Tartrate

Drug

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.

Other names: Exelbine (proposed), ANX-530

Primary outcomes

  1. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0-144 hours post dose

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0-144 hours post-dose

  3. Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)

    Time frame: 0-144 hours post-dose

    Determined Using the Linear Trapezoidal Rule

  4. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)

    Time frame: 0-144 hours post-dose

    AUCinf = AUClast + (Clast/lamda z)

  5. Percentage of AUCinf Based on Extrapolation (AUCextrap)

    Time frame: 0-144 hours post-dose

  6. Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)

    Time frame: 0-144 hours post-dose

    Estimated via linear regression of the time versus log concentration

  7. Observed Terminal Elimination Half-Life (t1/2)

    Time frame: 0-144 hours post-dose

    t1/2 = [ln(2)/λ z]

  8. Time of Last Measurable Concentration (Tlast)

    Time frame: 0-144 hours post-dose

  9. Last Quantifiable Drug Concentration (Clast)

    Time frame: 0-144 hours post-dose

  10. Mean Residence Time (MRTinf)

    Time frame: 0-144 hours post-dose

    MRT = (AUMCinf)/(AUCinf)

Sponsors and collaborators

Lead sponsor

Mast Therapeutics, Inc.

Industry

Collaborators

  • OCASA Soluciones Logísticas S.A.
  • Synteract, Inc.
  • Thywill Latam Solutions SRL
  • Worldwide Clinical Trials

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 8, 2007
Registry last updated
Feb 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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