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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015085-58 | EudraCT Number |
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The study was terminated due to safety reasons
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Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY79-4620 given every 2 weeks to patients with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY79-4620 | Drug | 1-hour infusion every 14 days. Starting dose will be 0.15 mg/ kg and dose will be escalated dependent on any dose limiting toxicities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event reporting | Approximately 3 years after initiation of the trial | |
| Pharmacokinetics profile of BAY79-4620 | End of cycle 2 (14 days per cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers evaluation | Approximately 3 years after initiation of the trial | |
| Tumor response evaluation | Approximately 3 years after initiation of the trial | |
| Immunogenicity evaluation |
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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 |
|---|---|---|---|---|---|---|
| Rotterdam | 3075 EA | Netherlands | ||||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Approximately 3 years after initiation of the trial |
| Utrecht |
| 3584 CX |
| Netherlands |