Trial Condition(s):

Hematologic neoplasms

Phase I trial of BAY1251152 for advanced blood cancers

Bayer Identifier:

18117

ClinicalTrials.gov Identifier:

NCT02745743

EudraCT Number:

2015-005122-18

Study Completed

Trial Purpose

The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.

Inclusion Criteria
- Male or female patients aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and Life expectancy of at least 12 weeks
- Patients are able and willing to provide bone marrow biopsies/aspirates as requested by the protocol
- Patients with confirmed advanced hematological malignancies
- Negative serum pregnancy test
- Women and men of reproductive potential must agree to use highly effective contraception when sexually active.
- Ability to understand and the willingness to sign a written informed consent.
- Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ≤1.5 times ULN)
- Adequate liver function (total bilirubin ≤ 1.5 times the ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
Exclusion Criteria
- Presence of active/uncontrolled central nervous system involvement
- History of clinically significant cardiac disease; uncontrolled hypertension
- Left ventricular ejection fraction (LVEF) < 45%
- Allogeneic stem cell transplant within 100 days before first dose of study drug
- Known history of human immunodeficiency virus (HIV) infection
- Chronic or active hepatitis B or C, requiring antiviral therapy
- Evidence of history of bleeding disorder, dialysis, or coexisting cancer that is distinct in primary site or histology from the cancer evaluated in this study
- Serious, uncontrolled infection
- Unresolved chronic toxicity > grade 1 from prior therapy
- Use of strong CYP3A4 inhibitors or strong inducers within 7 days prior to the start of study treatment and for the duration of the study

Trial Summary

Enrollment Goal
21
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1251152
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Nashville, United States, 37232

Status
Completed
 
Locations

Investigative Site

New York, United States, 10032

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28040

Status
Completed
 
Locations

Investigative Site

Bronx, United States, 10461

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Cardiff, United Kingdom, CF14 4XN

Status
Completed
 

Trial Design