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)
Phase of Trial: Phase III
Latest Information Update: 16 Nov 2017
At a glance
- Drugs Idasanutlin (Primary) ; Cytarabine
- Indications Acute myeloid leukaemia
- Focus Registrational; Therapeutic Use
- Sponsors Roche
- 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.