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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Non-small Cell Lung Cancer
Non-Hodgkins Lymphoma
Drug: Vinorelbine Tartrate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.

Resource links provided by NLM:


Further study details as provided by Mast Therapeutics, Inc.:

Primary Outcome Measures:
  • 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)


Enrollment: 31
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432562

Locations
Argentina
Clinical Investigative Site
Buenos Aires, Argentina
Clinical Investigative Site
Mendoza, Argentina
Clinical Investigative Site
Rosario, Argentina
Clinical Investigative Site
Santa Fe, Argentina
Clinical Investigative Site
Tucuman, Argentina
Sponsors and Collaborators
Mast Therapeutics, Inc.
Synteract, Inc.
Thywill Latam Solutions SRL
OCASA Soluciones Logísticas S.A.
Worldwide Clinical Trials Drug Development Solutions
Investigators
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
  More Information

No publications provided

Responsible Party: Chief Executive Officer, Adventrx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00432562     History of Changes
Other Study ID Numbers: 530-01
Study First Received: February 6, 2007
Results First Received: January 19, 2012
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vinorelbine
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014