To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors
| Status: | Archived |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2009 |
| End Date: | January 2012 |
An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors
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:
- side effects of BAY79-4620 given as infusion every three weeks
- evaluation of highest and safest dose of BAY79-4620
- distribution and concentration of BAY79-4620 in the blood at specific times after
administration
- effect of BAY79-4620 on tumor growth
- assessment of "biomarkers" (eg, analysis of specific proteins in blood samples, or
analysis of tumor tissue sampled at the time of cancer diagnosis) for changes during
the treatment or prediction of safety or benefits of the treatment with BAY79-4620.
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