A pilot study to assess the safety, tolerability, dose finding and efficacy of ORY-1001 in combination with azacitidine in older patients with AML in first line therapy
Phase of Trial: Phase II
Latest Information Update: 20 Sep 2018
At a glance
- Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Iadademstat (Primary)
- Indications Acute myeloid leukaemia
- Focus Adverse reactions
- Acronyms ALICE
- Sponsors Oryzon
- 15 Sep 2018 Status changed from planning to recruiting.
- 10 Sep 2018 According to an Oryzon media release, the company has received approval of a Clinical Trial Application (CTA), the European IND equivalent, from the Spanish Drug Agency (AEMPS) to conduct this trial. The trial will be carried out in two Spanish hospitals, "La Fe" in Valencia and "Valle de Hebron" in Barcelona.
- 30 Jul 2018 According to an Oryzon media release, the company has filed the corresponding CTA authorizations to Regulatory Agencies to carry out this trial, and will inform about its regulatory approval and the operational start thereof in due time.