A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies

Last updated: December 20, 2021
Sponsor: Bayer
Overall Status: Terminated

Phase

1

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT03404726
19420
2017-002896-24
  • Ages > 18
  • All Genders

Study Summary

The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).

The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with relapsed or refractory AML. Relapsed AML is defined as relapse afterachieving a response to initial therapy and refractory AML is defined as failure toachieve a response after one previous line of therapy. Response is defined as per IWGcriteria (CR, CRi or CRp). Patients who are not candidates to receive or who declinestandard of care therapy are also eligible.
  • Patients with intermediate-1 or higher risk MDS who have failed therapy with ahypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.
  • Patients with relapsed/refractory CMML.
  • Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m^2
  • Patients must have adequate coagulation (international normalized ratio [INR] ≤ 1.5;activated partial thromboplastin time [aPTT] ≤1.5 X the upper limit of normal [ULN];patients on chronic anticoagulation therapy at investigator's discretion; patients onchronic use of direct-acting oral anticoagulants who have acceptable benefit-riskratio at investigator's discretion)
  • Adequate liver function (total bilirubin ≤1.5 X ULN (or ≤3 X ULN in patients withdocumented Gilbert's syndrome or for patients with hyperbilirubinemia considered dueto myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] ≤3 X ULN (or ≤5 X ULN for patients with liver involvement of their myeloiddisease)

Exclusion

Exclusion Criteria:

  • Patients eligible for hematopoietic stem cell transplantation
  • Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNSleukemia
  • Human immunodeficiency virus (HIV) infection
  • Chronic or active hepatitis B or C if not controlled by antiviral therapy
  • History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3months prior to first dose of study drug
  • Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviraltherapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted
  • Left ventricular ejection fraction (LVEF) <40%

Study Design

Total Participants: 40
Study Start date:
March 29, 2018
Estimated Completion Date:
January 26, 2021

Connect with a study center

  • Institut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467-2490
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

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