Trial Profile
A bioequivalence study of vinorelbine tartrate injectable emulsion (ANX-530) in patients with advanced cancer.
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 26 Oct 2015
Price :
$35
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At a glance
- Drugs Vinorelbine (Primary)
- Indications Breast cancer; Cancer; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Solid tumours
- Focus Pharmacokinetics
- Sponsors Mast Therapeutics
- 14 Mar 2013 Additional lead trial centres identified as reported by ClinicalTrials.gov.
- 09 Aug 2011 The FDA reports in a Complete Response Letter that the results may not be valid and that this trial will need to be repeated.
- 20 Jan 2011 The FDA established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) NDA, acording to an Adventrix media release.