Phase I Trial of BAY1251152 for Advanced Blood Cancers

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02745743

Collaborator

(none)

Enrollment

Locations

Arms

25.5

Actual Duration (Months)

3.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Neoplasms	Drug: BAY1251152	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 17, 2016

Actual Primary Completion Date :

Aug 3, 2018

Actual Study Completion Date :

Aug 3, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose(MTD) [21 days]
To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms
Recommended Phase 2 dose (RP2D) [Up to 30 months]
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) [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
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 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 [Up to 30 months]
To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Bronx	New York	United States	10461
2	New York	New York	United States	10032
3	Nashville	Tennessee	United States	37232
4	Dresden	Sachsen	Germany	01307
5	Madrid		Spain	28040
6	Cardiff		United Kingdom	CF14 4XN