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Phase I Trial of BAY1251152 for Advanced Blood Cancers

Primary Purpose

Hematologic Neoplasms

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BAY1251152

About this trial

This is an interventional treatment trial for Hematologic Neoplasms focused on measuring Phase 1, Dose escalation, Dose expansion, Positive transcription elongation factor b inhibitor, Cyclin-dependent kinase 9 inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Biomarker-enriched advanced hematological neoplasms

Other selected advanced hematological neoplasms

Outcomes

Primary Outcome Measures

Maximum tolerated dose(MTD)

To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms

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

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

Pharmacokinetics (PK) is determined by maximum concentration (Cmax)

Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02745743

First Posted

April 18, 2016

Last Updated

September 18, 2019

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02745743

Brief Title

Phase I Trial of BAY1251152 for Advanced Blood Cancers

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 17, 2016 (Actual)

Primary Completion Date

August 3, 2018 (Actual)

Study Completion Date

August 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Neoplasms

Keywords

Phase 1, Dose escalation, Dose expansion, Positive transcription elongation factor b inhibitor, Cyclin-dependent kinase 9 inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Biomarker-enriched advanced hematological neoplasms

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Other selected advanced hematological neoplasms

Intervention Type

Drug

Intervention Name(s)

BAY1251152

Intervention Description

Weekly infusion of BAY1251152 in 21-day cycles.

Primary Outcome Measure Information:

Title

Maximum tolerated dose(MTD)

Description

To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms

Time Frame

21 days

Title

Recommended Phase 2 dose (RP2D)

Description

To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms

Time Frame

Up to 30 months

Title

Number of adverse events (AE)

Description

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

Time Frame

Up to 30 months

Title

Pharmacokinetics (PK) is determined by maximum concentration (Cmax)

Time Frame

21 days

Title

Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from

Description

To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms

Time Frame

Up to 30 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

City

Madrid

ZIP/Postal Code

28040

Country

Spain

City

Cardiff

ZIP/Postal Code

CF14 4XN

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Phase I Trial of BAY1251152 for Advanced Blood Cancers

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