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Completed

NCT Number: NCT02745743

Phase I Trial of BAY1251152 for Advanced Blood Cancers

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.

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Key information

Conditions

Hematologic Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dresden, Saxony, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1251152

Drug

Weekly infusion of BAY1251152 in 21-day cycles.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2016
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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