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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)

Description

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)

Phase

N/A

Inclusion and Exclusion Criteria

  • Patients with advanced AML that harbors IDH1 mutation
  • Patients are relapsed from or refractory to at least 1 previous line of therapy
  • Good kidney and liver function
  • Male or female patients
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal

  • Previously treated with any prior mIDH1 targeted therapy
  • Extramedullary disease only
  • History of clinically significant or active cardiac disease
  • Active clinically significant infection
  • Unresolved chronic toxicity of previous AML treatment
  • Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors
  • Pregnancy or breast-feeding

Sites

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