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Phase I Trial of BAY1251152 for Advanced Blood Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02745743
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Drug: BAY1251152 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Phase I Study to Characterize the Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY1251152 in Patients With Advanced Hematological Malignancies
Actual Study Start Date : June 17, 2016
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : August 3, 2018

Arm Intervention/treatment
Experimental: Arm 1
Biomarker-enriched advanced hematological neoplasms
Drug: BAY1251152
Weekly infusion of BAY1251152 in 21-day cycles.

Experimental: Arm 2
Other selected advanced hematological neoplasms
Drug: BAY1251152
Weekly infusion of BAY1251152 in 21-day cycles.

Primary Outcome Measures :
  1. Maximum tolerated dose(MTD) [ Time Frame: 21 days ]
    To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms

  2. Recommended Phase 2 dose (RP2D) [ Time Frame: Up to 30 months ]
    To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms

  3. Number of adverse events (AE) [ Time Frame: Up to 30 months ]
    For assessment of the safety (ECG, vital signs, clinical significant abnormal laboratory results… etc.)and tolerability of BAY 1251152 in subjects with advanced hematological neoplasms

  4. Pharmacokinetics (PK) is determined by maximum concentration (Cmax) [ Time Frame: 21 days ]
  5. Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC) [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from [ Time Frame: Up to 30 months ]
    To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02745743

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United States, New York
Bronx, New York, United States, 10461
New York, New York, United States, 10032
United States, Tennessee
Nashville, Tennessee, United States, 37232
Dresden, Sachsen, Germany, 01307
Madrid, Spain, 28040
United Kingdom
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer Identifier: NCT02745743    
Other Study ID Numbers: 18117
2015-005122-18 ( EudraCT Number )
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Phase 1
Dose escalation
Dose expansion
Positive transcription elongation factor b inhibitor
Cyclin-dependent kinase 9 inhibitor
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases