Phase I Trial of BAY1251152 for Advanced Blood Cancers

Bayer

Status and phase

Completed

Phase 1

Conditions

Hematologic Neoplasms

Treatments

Drug: BAY1251152

Study type

Interventional

Funder types

Industry

Identifiers

NCT02745743

2015-005122-18 (EudraCT Number)

18117

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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