Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090545
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2004-08-27
Brief Title:
A Phase II Study of BAY 43-9006 Sorafenib in Metastatic Androgen-Independent Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of BAY 43-9006 Sorafenib in Metastatic Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 drugs 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 andor 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
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 drugs 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 andor 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
Detailed Description:
BAY 43-9006 Sorafenib is a potent inhibitor of wild-type and mutant b-Raf and c-Raf kinase isoforms in vitro In addition this agent also inhibits p38 c-kit vascular endothelial growth factor receptor 2 VEGFR-2 and platelet-derived growth factor receptor beta PDGFR-beta affecting tumor growth as well as possibly promoting apoptosis by events downstream of c-Raf At this time over 500 patients have been treated with this drug with tolerable side effects
The primary objective of this study is to determine if BAY 43-9006 Sorafenib is associated with a 50 4 month probability of progression free survival in patients with metastatic androgen independent prostate cancer AIPC as determined by clinical radiographic and prostatic specific antigen PSA criteria
The secondary objective of this study will be demonstration of biologic effect by the drug in the patient and on the tumor when possible Correlative studies will be conducted on serially obtained tissue biopsies bone marrow biopsies and white blood cell collections These laboratory correlates will include elucidation of activation of components of the Raf-extracellular-signal regulated kinase ERK-methyl ethyl ketone MEK and angiogenesis pathways using protein microarray technologies developed by the National Cancer Institute NCIFood and Drug Administration FDA clinical proteomics program
Per Amendment D a secondary objective of this study will also be to determine the time to progression measured by clinical and radiographic criteria The 22 patients treated on the first stage of this protocol will be retrospectively evaluated with respect to this secondary endpoint possible Please refer to the statistics section for further details
The combination of correlated clinical and laboratory endpoints with emphasis on molecular signaling will provide new information on the anti-tumor effects helping to characterize its role in the treatment of androgen independent prostate cancer AIPC
The primary objective of this study is to determine if BAY 43-9006 Sorafenib is associated with a 50 4 month probability of progression free survival in patients with metastatic androgen independent prostate cancer AIPC as determined by clinical radiographic and prostatic specific antigen PSA criteria
The secondary objective of this study will be demonstration of biologic effect by the drug in the patient and on the tumor when possible Correlative studies will be conducted on serially obtained tissue biopsies bone marrow biopsies and white blood cell collections These laboratory correlates will include elucidation of activation of components of the Raf-extracellular-signal regulated kinase ERK-methyl ethyl ketone MEK and angiogenesis pathways using protein microarray technologies developed by the National Cancer Institute NCIFood and Drug Administration FDA clinical proteomics program
Per Amendment D a secondary objective of this study will also be to determine the time to progression measured by clinical and radiographic criteria The 22 patients treated on the first stage of this protocol will be retrospectively evaluated with respect to this secondary endpoint possible Please refer to the statistics section for further details
The combination of correlated clinical and laboratory endpoints with emphasis on molecular signaling will provide new information on the anti-tumor effects helping to characterize its role in the treatment of androgen independent prostate cancer AIPC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-0262 | None | None | None |