Trial Condition(s):

Leukemia

Phase I dose escalation of BAY1143572 in subjects with acute leukemia

Bayer Identifier:

16520

ClinicalTrials.gov Identifier:

NCT02345382

EudraCT Number:

2014-000410-57

Study Completed

Trial Purpose

To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, and recommended Phase II dose of BAY1143572 in a once-daily or an intermittent dosing schedule in subjects with advanced acute leukemia

Inclusion Criteria
- Male or female subjects aged >/=18 years
 - Subjects with a histologically or cytologically confirmed acute leukemia who are refractory to or have exhausted all available therapies
 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
 - Life expectancy of at least 12 weeks
 - Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 14 days before the first dose of study drug:
 -- Total bilirubin </=1.5 times the upper limit of normal (ULN)
 -- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </=2.5 times ULN (</=5 times ULN for subjects with liver involvement of their cancer)
 -- International normalized ratio (INR) </=1.5 times ULN
 -- Estimated glomerular filtration rate (eGFR) >/=50 mL/min per 1.73 m2 according to the Modification of Diet in Renal Disease Study Group (MDRD) formula
 - Negative serum or urine pregnancy test must be obtained within 7 days before the first dose of study drug in women of childbearing potential. Negative results must be available before study drug administration
 - Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and 30 days after the last administration of study drug. Highly effective contraception includes a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, hysterectomy, or vasectomy of the partner. In addition, the use of condoms for subjects or their partners is required.
Exclusion Criteria
- Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study
 - History of cardiac disease including congestive heart failure New York Heart Association (NYHA) Class >/=III, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months or cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. major regional wall motion abnormalities on baseline echocardiography or a left ventricular ejection fraction (LVEF) <45%)
 - Previous pulmonary embolism within 12 months before study entry
 - Uncontrolled hypertension defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg, despite optimal medical management and stable antihypertensive treatment for more than 7 days before the first dose of study drug
 - Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C 
 - Known history of human immunodeficiency virus (HIV) infection
 - Chronic or active hepatitis B or C, requiring antiviral therapy
 - Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy
 - Uncontrolled meningeal leukemia
 - Prior allogeneic hematopoietic stem cell transplant within </=4 months before first dose of study drug (Subjects must have completed immunosuppressive therapy before enrollment.

Trial Summary

Enrollment Goal
42
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Atuveciclib (BAY1143572)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum der Johann Wolfgang Goethe Universität

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Dana-Farber Cancer Institute

Boston, United States, 02215

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Columbia University Medical Center

New York, United States, 10032

Status
Completed
 
Locations

Medical University of South Carolina

Charleston, United States, 29425

Status
Completed
 
Locations

Vanderbilt University Medical Center

Nashville, United States, 37232

Status
Completed
 
Locations

Hackensack University Medical Center

Hackensack, United States, 07601

Status
Completed
 

Trial Design