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



Status:Recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 29, 2018
End Date:December 14, 2020
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+) 1-888-8422937

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An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies

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).


Inclusion Criteria:

- Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after
achieving a response to initial therapy and refractory AML is defined as failure to
achieve a response after one previous line of therapy. Response is defined as per IWG
criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline
standard of care therapy are also eligible.

- Patients with intermediate-1 or higher risk MDS who have failed therapy with a
hypomethylating 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 on
chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk
ratio at investigator's discretion)

- Adequate liver function (total bilirubin ≤1.5 X ULN (or ≤3 X ULN in patients with
documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due
to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase
[AST] ≤3 X ULN (or ≤5 X ULN for patients with liver involvement of their myeloid
disease)

Exclusion Criteria:

- Patients eligible for hematopoietic stem cell transplantation

- Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS
leukemia

- 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 3
months prior to first dose of study drug

- Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral
therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted

- Left ventricular ejection fraction (LVEF) <40%
We found this trial at
5
sites
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Villejuif Cedex, 94805
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Villejuif Cedex,
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