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Sponsored by: |
Adventrx Pharmaceuticals |
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Information provided by: | Adventrx Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00432562 |
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 |
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Breast Cancer Non-Small Cell Lung Cancer Non-Hodgkins Lymphoma |
Drug: Vinorelbine Tartrate |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Argentina | |
Clinical Investigative Site | |
Rosario, Argentina | |
Clinical Investigative Site | |
Tucuman, Argentina | |
Clinical Investigative Site | |
Santa Fe, Argentina | |
Clinical Investigative Site | |
Buenos Aires, Argentina | |
Clinical Investigative Site | |
Mendoza, Argentina |
Study ID Numbers: | 530-01 |
Study First Received: | February 6, 2007 |
Last Updated: | November 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00432562 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Immunoproliferative Disorders Skin Diseases Breast Neoplasms Vinblastine Antimitotic Agents Carcinoma Lymphoma, Small Cleaved-cell, Diffuse Hydroxyzine Lymphatic Diseases Vinorelbine Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Lymphoma Carcinoma, Non-Small-Cell Lung Breast Diseases Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Vinblastine Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lymphoma Breast Diseases Respiratory Tract Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Skin Diseases Immune System Diseases |
Mitosis Modulators Breast Neoplasms Antimitotic Agents Pharmacologic Actions Carcinoma Lymphatic Diseases Neoplasms Vinorelbine Lung Diseases Tubulin Modulators Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |