A bioequivalence study of vinorelbine tartrate injectable emulsion (ANX-530) in patients with advanced cancer.
Phase of Trial: Phase I
Latest Information Update: 26 Oct 2015
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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History