Phase I Trial of BAY1251152 for Advanced Blood Cancers

NCT02745743 | Completed Phase 1 FDA Drug

• 2 other identifiers: 181172015-005122-18
• Study Type: interventional
• Target: 21
• Locations: 4 countries
• Sites: 6

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.

Conditions

Hematologic Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Maximum tolerated dose(MTD)

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

  21 days

• 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

  Up to 30 months

• 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

  Up to 30 months

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

  21 days

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

  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

  Up to 30 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Biomarker-enriched advanced hematological neoplasms

Drug: BAY1251152

Arm 2

EXPERIMENTAL

Other selected advanced hematological neoplasms

Drug: BAY1251152

Interventions

BAY1251152 DRUG

Weekly infusion of BAY1251152 in 21-day cycles.

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (6)

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

The Bronx, New York, 10461, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Cardiff, CF14 4XN, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: June 17, 2016
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

GB (1); ES (1); US (3); DE (1)