A Multi-Center, Open-Label, Phase 1/1b Study of Escalating Doses of RO5503781 Administered Orally as 1) a Single Agent, 2) In Combination With Cytarabine, or 3) With Cytarabine and Anthracycline and 4) Assessing PK and Safety of New Optimized Formulation of RO5503781 With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)

Trial Profile

A Multi-Center, Open-Label, Phase 1/1b Study of Escalating Doses of RO5503781 Administered Orally as 1) a Single Agent, 2) In Combination With Cytarabine, or 3) With Cytarabine and Anthracycline and 4) Assessing PK and Safety of New Optimized Formulation of RO5503781 With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)

Completed
Phase of Trial: Phase I

Latest Information Update: 02 Feb 2017

At a glance

  • Drugs Cytarabine (Primary) ; Idasanutlin (Primary) ; Anthracyclines
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Roche
  • Most Recent Events

    • 06 Dec 2016 Results assessing minimal residual disease in relapsed/refractory AML patients treated with idasanutlin presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 01 Aug 2016 Status changed from active, no longer recruiting to completed.
    • 01 Feb 2016 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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