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This is the first time this drug will be tested in humans in order to determine the safety of the drug, the ability to tolerate the drug, to measure how the drug is used in the body and as a result of these tests to determine a maximum dose to be given. Specifically, the following aspects will be investigated:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY79-4620 | Drug | BAY79-4620 will be administered as 1 hour IV infusion. Dose escalation will be dependent on any dose limiting toxicities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability, maximum tolerated dose | 2 years | |
| Pharmacokinetics profile of BAY79-4620 and its key metabolites | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker evaluation | 2 years | |
| Tumor response | 2 years | |
| Immunogenicity |
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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 |
|---|---|---|---|---|---|---|
| Nashville | Tennessee | 37203 | United States | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 2 years |
| San Antonio |
| Texas |
| 78229-3307 |
| United States |