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| 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
More Information
| 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 |
|
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 |