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A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
This study has been completed.

First Received on February 6, 2007.   Last Updated on November 15, 2007   History of Changes
Sponsor: Adventrx Pharmaceuticals
Information provided by: Adventrx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00432562
  Purpose

This study is a randomized, single dose crossover comparison of the investigational product with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective is 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 I

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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 Adventrx Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence with reference product.

Estimated Enrollment: 28
Study Start Date: February 2007
  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
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
Adventrx Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00432562     History of Changes
Other Study ID Numbers: 530-01
Study First Received: February 6, 2007
Last Updated: November 15, 2007
Health Authority: United States: Food and Drug Administration

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 February 12, 2012