Phase I Trial of BAY1251152 for Advanced Blood Cancers

September 18, 2019 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
  • Spain
      • Madrid, Spain, 28040
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XN
  • United States
    • New York
      • Bronx, New York, United States, 10461
      • New York, New York, United States, 10032
    • Tennessee
      • Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose(MTD)
Time Frame: 21 days
To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms
21 days
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
Up to 30 months
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
Up to 30 months
Pharmacokinetics (PK) is determined by maximum concentration (Cmax)
Time Frame: 21 days
21 days
Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 17, 2016

Primary Completion (ACTUAL)

August 3, 2018

Study Completion (ACTUAL)

August 3, 2018

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (ESTIMATE)

April 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18117 (Other Identifier: City of Hope Comprehensive Cancer Center)
  • 2015-005122-18 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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