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A Phase 1/2, Open-Label, Multi-Center Dose Escalation, Safety and Tolerability Study of AKN-028 in Patients with Acute Myelogenous Leukemia (AML).

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Trial Profile

A Phase 1/2, Open-Label, Multi-Center Dose Escalation, Safety and Tolerability Study of AKN-028 in Patients with Acute Myelogenous Leukemia (AML).

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs AKN 028 (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Akinion Pharmaceuticals

    • Most Recent Events

    • 24 Mar 2016 Status changed from recruiting to discontinued as two patients have experienced serious liver events related to AKN-028, The risk-benefit balance was judged to be negative as reported by ClinicalTrials.gov.
    • 02 Feb 2016 Planned End Date changed from 1 Sep 2016 to 1 Aug 2016 as reported by ClinicalTrials.gov.
    • 02 Feb 2016 Planned primary completion date changed from 1 Sep 2016 to 1 Aug 2016 as reported by ClinicalTrials.gov.

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