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Clinical Trials Insight: 700052535

Trial Profile

Clinical Trials Insight: 700052535

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 02 Mar 2010

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At a glance

  • Drugs Laromustine (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Vion Pharmaceuticals
  • Most Recent Events

    • 27 Feb 2010 In response to the SPA filing for this phase II/III trial, the FDA requested that Vion conduct a separate phase II trial prior to initiation of a phase III trial, according to a Vion media release.
    • 14 Jan 2010 New trial record
    • 12 Jan 2010 According to a Vion Pharmaceuticals media release, a Special Protocol Assessment has been filed in response to the FDAs complete response letter to the Companys New Drug Application for Onrigin for the treatment of AML.
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