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Tracking Information | |
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First Received Date † | February 6, 2007 |
Last Updated Date | November 15, 2007 |
Start Date † | February 2007 |
Current Primary Outcome Measures † |
Bioequivalence with reference product. |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00432562 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer. |
Official Title † | A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer. |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase I |
Study Type † | Interventional |
Study Design † | Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study |
Condition † |
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Intervention † | Drug: Vinorelbine Tartrate |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 28 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | Argentina |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00432562 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | Adventrx Pharmaceuticals |
Collaborators †† | |
Investigators † | |
Information Provided By | Adventrx Pharmaceuticals |
Verification Date | November 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |