A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Trial Profile

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Idasanutlin (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Roche
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 30 May 2017 Protocol has been amended to change in the endpoint and treatment arms.
    • 30 May 2017 Planned primary completion date changed from 5 Jun 2019 to 31 Dec 2018.
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