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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