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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

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Trial Profile

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

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Tumour cells apoptosis factor (Primary) ; Doxorubicin
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Immune System Key

Most Recent Events

  • 29 Jul 2020 Planned initiation date changed from 1 Sep 2018 to 25 Oct 2018.
  • 29 Jul 2020 Planned End Date changed from 1 Dec 2020 to 26 Jul 2020.
  • 29 Jul 2020 Planned primary completion date changed from 1 Jul 2020 to 26 Jul 2020.

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