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

This study has been completed.
Sponsor:
Collaborators:
Synteract, Inc.
Thywill Latam Solutions SRL
OCASA Soluciones Logísticas S.A.
Worldwide Clinical Trials Drug Development Solutions
Information provided by:
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00432562
First received: February 6, 2007
Last updated: January 19, 2012
Last verified: January 2012

February 6, 2007
January 19, 2012
February 2007
November 2007   (final data collection date for primary outcome measure)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0-144 hours post dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Determined Using the Linear Trapezoidal Rule
  • Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
    AUCinf = AUClast + (Clast/lamda z)
  • Percentage of AUCinf Based on Extrapolation (AUCextrap) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  • Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
    Estimated via linear regression of the time versus log concentration
  • Observed Terminal Elimination Half-Life (t1/2) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
    t1/2 = [ln(2)/λ z]
  • Time of Last Measurable Concentration (Tlast) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  • Last Quantifiable Drug Concentration (Clast) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
  • Mean Residence Time (MRTinf) [ Time Frame: 0-144 hours post-dose ] [ Designated as safety issue: No ]
    MRT = (AUMCinf)/(AUCinf)
Bioequivalence with reference product.
Complete list of historical versions of study NCT00432562 on ClinicalTrials.gov Archive Site
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Not Provided
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A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) 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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Non-Hodgkins Lymphoma
Drug: Vinorelbine Tartrate
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00432562
530-01
No
Chief Executive Officer, Adventrx Pharmaceuticals, Inc.
Mast Therapeutics, Inc.
  • Synteract, Inc.
  • Thywill Latam Solutions SRL
  • OCASA Soluciones Logísticas S.A.
  • Worldwide Clinical Trials Drug Development Solutions
Principal Investigator: Lino Arboit, M.D. Fundación Centro Oncológico de Integración Regional - COIR.
Principal Investigator: Gerardo F Arroyo, M.D. Hospital Privado De Santa Clara De Asis
Principal Investigator: Cesar R Blajman, M.D. Isis Clínica Especializada
Principal Investigator: Matias Chacon, M.D. Instituto Médico Espcializado Alexander Fleming
Principal Investigator: Luis E Fein, M.D. Centro Oncológico
Principal Investigator: Hugo R. Requejo, M.D. Hospital Regional De Concepción
Principal Investigator: Edgar P Quintana, M.D. CIMA Salud
Mast Therapeutics, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP