A Multi-Center, Open-Label, Phase I/II Study Of Kevetrin With Cytarabine In Patients With Acute Myelogenous Leukemia (AML)

Trial Profile

A Multi-Center, Open-Label, Phase I/II Study Of Kevetrin With Cytarabine In Patients With Acute Myelogenous Leukemia (AML)

Planning
Phase of Trial: Phase II

Latest Information Update: 21 Apr 2015

At a glance

  • Drugs Thioureidobutyronitrile (Primary) ; Cytarabine; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 21 Apr 2015 Planned initiation date changed to 1 May 2015. The new protocol will be submitted in May by the principal investigator at the University of Bologna to the institutional committee, according to a Cellceutix Corporation media release.
    • 21 Apr 2015 Planned number of patients changed to 100. Over 100 patients are expected to be enrolled in the trial, according to a Cellceutix Corporation media release.
    • 21 Apr 2015 The original protocol has been revised and expanded from what was originally planned to be a Phase 1b study into a Phase 2 trial evaluating Kevetrin as a single agent or in combination with cytarabine in patients with Acute Myelogenous Leukemia (AML). The new protocol will be submitted in May by the principal investigator at the University of Bologna to the institutional committee, according to a Cellceutix Corporation media release.
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