Status:
TERMINATED
A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies
Lead Sponsor:
Bayer
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 leukem...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03404726
Start Date
March 29 2018
End Date
January 26 2021
Last Update
January 11 2022
Active Locations (5)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
2
Montefiore Medical Center
The Bronx, New York, United States, 10467-2490
3
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232