A phase 2b study of astarabine for treatment of newly diagnosed acute myeloid leukaemia patients unfit for standard chemotherapy

Trial Profile

A phase 2b study of astarabine for treatment of newly diagnosed acute myeloid leukaemia patients unfit for standard chemotherapy

Planning
Phase of Trial: Phase II

Latest Information Update: 16 May 2016

At a glance

  • Drugs Astarabine (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Most Recent Events

    • 16 May 2016 According to a BioSight media release, the company will receive funding from a $US13M investment to conduct this trial.
    • 28 Oct 2015 New trial record
    • 26 Oct 2015 FDA and BioSight agreed regarding the study design and the data required for an IND application, and the FDA confirmed that the application would be considered as a 505(b)(2). The FDA also indicated that this trial could potentially support a Breakthrough Therapy Designation request.
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