Hematologic Neoplasms
Conditions
Keywords
Phase 1, Dose escalation, Dose expansion, Positive transcription elongation factor b inhibitor, Cyclin-dependent kinase 9 inhibitor
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.
Interventions
DRUGBAY1251152
Weekly infusion of BAY1251152 in 21-day cycles.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany, Spain, United Kingdom, United States
Outcome results
None listed