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)

Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Jun 2017

At a glance

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

    • 21 Jun 2017 Status changed from not yet recruiting to recruiting.
    • 22 May 2017 Planned End Date changed from 28 Sep 2019 to 11 Oct 2019.
    • 22 May 2017 Planned initiation date changed from 28 Apr 2017 to 30 Jun 2017.
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