Phase I Dose Escalation of BAY1143572 in Subjects With Acute Leukemia



Status:Completed
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/27/2018
Start Date:February 19, 2015
End Date:July 30, 2017

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An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY1143572 Given in a Once-daily or an Intermittent Dosing Schedule in Subjects With Advanced Acute Leukemia

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
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ULN (
- International normalized ratio (INR)
- 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 dose of study drug (Subjects must have completed immunosuppressive therapy before
enrollment.
We found this trial at
6
sites
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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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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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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7 Theodor-Stern-Kai
Frankfurt, Hessen 60596
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Frankfurt,
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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