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An Open-label, Non-randomized, Multicenter Phase I Study to Determine the Maximum Tolerated and / or Recommended Phase II Dose of Oral Mutant IDH1 (mIDH1) Inhibitor BAY1436032 and to Characterize Its Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Efficacy in Patients With mIDH1-R132X Advanced Acute Myeloid Leukemia (AML)

Trial Profile

An Open-label, Non-randomized, Multicenter Phase I Study to Determine the Maximum Tolerated and / or Recommended Phase II Dose of Oral Mutant IDH1 (mIDH1) Inhibitor BAY1436032 and to Characterize Its Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Efficacy in Patients With mIDH1-R132X Advanced Acute Myeloid Leukemia (AML)

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Jan 2019

At a glance

  • Drugs BAY 1436032 (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Bayer
  • Most Recent Events

    • 26 Dec 2018 Planned End Date changed from 11 Oct 2019 to 6 Mar 2019.
    • 26 Nov 2018 Planned primary completion date changed from 31 Aug 2019 to 8 Dec 2018.
    • 26 Nov 2018 Status changed from recruiting to active, no longer recruiting.
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