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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.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Oct 2015

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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
  • 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.
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