A Phase 2a, Open-Label, Two Stage Study: Stage A: Dose-Range Finder Study to Assess the Safety and Efficacy of Two Doses of Nerofe and Two Doses of Nerofe in Combination With Doxorubicin in Subjects With Acute Myelogenous Leukemia or High Risk Myelodysplastic Syndrome (AML/High Risk MDS). Stage B: Dose Confirmation Study to Assess the Safety and Efficacy of Nerofe or Nerofe in Combination With Doxorubicin in Subjects With AML/ High Risk MDS
Phase of Trial: Phase II
Latest Information Update: 30 Aug 2018
At a glance
- Drugs Doxorubicin (Primary) ; Tumour cells apoptosis factor (Primary)
- Indications Acute myeloid leukaemia; Myelodysplastic syndromes
- Focus Adverse reactions; Therapeutic Use
- Sponsors Immune System Key
- 08 Aug 2018 Planned initiation date (estimated date for recruitment of the first subject) changed from 1 Jul 2018 to 1 Sep 2018, as reported in the ClinicalTrials.gov record.
- 08 Jul 2018 Status changed from not yet recruiting to recruiting.
- 17 Jun 2018 Planned number of patients changed from 22 to 29.