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.
Brief Title
Phase I Trial of BAY1251152 for Advanced Blood Cancers
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hematologic Neoplasms
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Phase 1
Dose escalation
Dose expansion
Positive transcription elongation factor b inhibitor
Cyclin-dependent kinase 9 inhibitor
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02745743
Org Class
Industry
Org Full Name
Bayer
Org Study Id
18117
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms
Outcome Measure
Maximum tolerated dose(MTD)
Outcome Time Frame
21 days
Outcome Description
To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms
Outcome Measure
Recommended Phase 2 dose (RP2D)
Outcome Time Frame
Up to 30 months
Outcome 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
Outcome Measure
Number of adverse events (AE)
Outcome Time Frame
Up to 30 months
Outcome Measure
Pharmacokinetics (PK) is determined by maximum concentration (Cmax)
Outcome Time Frame
21 days
Outcome Measure
Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)
Outcome Time Frame
21 days
Secondary Ids
Secondary Id
2015-005122-18
Secondary Outcomes
Outcome Description
To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms
Outcome Time Frame
Up to 30 months
Outcome Measure
Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Amit Verma
Investigator Email
amit.verma@einsteinmed.org
Investigator Phone
718-405-8505 / 718-904-2900
Categories Mesh Debug
Blood & Bone Marrow Cancers --- HEMATOLOGIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
MeSH Terms
HEMATOLOGIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES