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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005122-18 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Biomarker-enriched advanced hematological neoplasms |
|
| Arm 2 | Experimental | Other selected advanced hematological neoplasms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1251152 | Drug | Weekly infusion of BAY1251152 in 21-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York | New York | 10032 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| The Bronx |
| New York |
| 10461 |
| United States |
| Nashville | Tennessee | 37232 | United States |
| Dresden | Saxony | 01307 | Germany |
| Madrid | 28040 | Spain |
| Cardiff | CF14 4XN | United Kingdom |