Trial Profile
Clinical Trials Insight: 700052535
Status:
Planning
Phase of Trial:
Phase II/III
Latest Information Update: 02 Mar 2010
Price :
$35
*
At a glance
- Drugs Laromustine (Primary) ; Cytarabine
- 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.