A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
BAY 43-9006 (Sorafenib) is an experimental cancer drug produced by Bayer Health Care
Corporation. It represents a new class of anticancer agents known as bi-aryl ureas. This
study will investigate its effect on prostate cancer and its side effects. Researchers expect
to enroll a maximum of 46 men with prostate cancer for this study. The duration of the study
will depend on its results.
Before beginning to take the drug, patients will be admitted to the hospital for 2 days, have
a medical examination and give blood samples, and have a tumor or bone marrow biopsy. On the
first day of the study, patients will begin taking the drug as 2 tablets twice daily, morning
and evening. Blood will be taken throughout the day to determine the drug's level in the
bloodstream.
Patients will be discharged from the hospital on the second day, and will continue to take
the drug twice daily until instructed to stop. During each of the first 4 weeks, patients
will be required to have their blood pressure checked. At the end of the first 4 weeks,
patients will have a physical examination and blood tests, as well as a second tumor or bone
marrow biopsy.
After the first 4 weeks, patients will continue with their drug regimen. At the end of each
4-week cycle, patients will have a physical examination and blood tests. Patients will also
have x-Rays, computed tomography (CT) scans, and/or magnetic resonance imaging (MRIs) at
every other 4-week examination or as required. Patients will be asked to keep a diary
recording the time and amount of their medication for this study.