A bioequivalence study of vinorelbine tartrate injectable emulsion (ANX-530) in patients with advanced cancer.

Trial Profile

A bioequivalence study of vinorelbine tartrate injectable emulsion (ANX-530) in patients with advanced cancer.

Completed
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top