At a glance
ClinicalIndex Comparison Record- ✓Histopathologically confirmed prostate cancer
- ✓Metastatic progressive androgen-independent prostate cancer with radiographic evidence of disease progression despite hormonal therapy
- ✓Progressive disease measured by expanding lesions, new lesions, or rising PSA
- ✓No more than 1 prior cytotoxic chemotherapy line
- ✕Patients with chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C, >3 months for suramin) or unrecovered from prior adverse events
- ✕Concurrent investigational agents
- ✕Known brain metastases
- ✕Uncontrolled hypertension (systolic >170 mmHg or diastolic >100 mmHg)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating BAY 43-9006 for Prostate Cancer. Completed, enrolled 46 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
400 mg BAY 43-9006 orally twice daily in 28 day cycles.