A phase 2b study of astarabine for treatment of newly diagnosed acute myeloid leukaemia patients unfit for standard chemotherapy
Phase of Trial: Phase II
Latest Information Update: 16 May 2016
At a glance
- Drugs Astarabine (Primary)
- Indications Acute myeloid leukaemia
- Focus Therapeutic Use
- 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.