Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432562
Status:
COMPLETED
Last Update Posted:
2012-02-23
First Post:
2007-02-06
Brief Title:
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer
Sponsor:
Mast Therapeutics Inc
Organization:
Mast Therapeutics Inc
Study Overview
Official Title:
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion ANX-530 in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None