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)
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 13 Jan 2022
Price :
$35
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At a glance
- Drugs Idasanutlin (Primary) ; Cytarabine
- Indications Acute myeloid leukaemia
- Focus Registrational; Therapeutic Use
- Acronyms MIRROS
- Sponsors Roche
- 21 Apr 2021 Status changed from completed to discontinued.
- 11 Apr 2021 Status changed from discontinued to completed.
- 08 Dec 2020 Results investigating the contribution of Idasanutlin exposure variability to those findings, in particular, the relationship between exposure and toxicity and efficacy in pts with AML from NCT02545283, NCT01773408, NCT01462175 and NCT03287245 presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.