Clinical Trials Insight: 700052535
Phase of Trial: Phase II/III
Latest Information Update: 27 Feb 2010
At a glance
- Drugs Cytarabine; Laromustine
- Indications Acute myeloid leukaemia
- Focus Registrational; Therapeutic Use
- Sponsors Vion Pharmaceuticals
- 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.