check_circleStudy Completed

Hematologic neoplasms

Bayer Identifier:

18117

ClinicalTrials.gov Identifier:

NCT02745743

EudraCT Number:

2015-005122-18

EU CT Number:

Not Available
Phase I trial of BAY1251152 for advanced blood cancers

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
June 2016 - August 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1251152
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Nashville, 37232, United States
Completed
New York, 10032, United States
Completed
Madrid, 28040, Spain
Withdrawn
Houston, 77030, United States
Completed
Bronx, 10461, United States
Completed
Dresden, 01307, Germany
Completed
Cardiff, CF14 4XN, United Kingdom

Primary Outcome

  • Maximum tolerated dose(MTD)
    To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms
    date_rangeTime Frame:
    21 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Recommended Phase 2 dose (RP2D)
    To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of adverse events (AE)
    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
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Pharmacokinetics (PK) is determined by maximum concentration (Cmax)
    date_rangeTime Frame:
    21 days
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)
    date_rangeTime Frame:
    21 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from
    To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
2

Additional Information

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