Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107432
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2005-04-05
Brief Title:
Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of BAY 43-9006 NSC 724772 in Patients With Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase II trial is studying how well sorafenib works in treating patients with malignant mesothelioma Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rate partial response PR and complete response CR in patients with malignant mesothelioma treated with BAY 43-9006
SECONDARY OBJECTIVES
I To determine 3-month failure free survival in patients with malignant mesothelioma treated with BAY 43-9006
II To describe the median and overall survival of malignant mesothelioma patients treated with BAY 43-9006
III To describe the toxicity profile of BAY 43-9006 in patients with malignant mesothelioma
IV To determine whether mesotheliomas contain mutations in exons 11 and 15 of the B-raf gene and correlate these findings with anti-tumor activity of BAY 43-9006
V To determine whether the amount of expression of phospho-ERK12 as determined by immunohistochemistry from pre-treatment tumor specimens correlates with anti-tumor activity of BAY 43-9006 in patients with mesothelioma
VI To determine whether baseline levels and changes following BAY 43-9006 treatment in angiogenic cytokines VEGF and PDGF correlate with anti-tumor activity of BAY 43-9006
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at least every 2 months for 1 year every 4 months for 1 year and then every 6 months for 1 year
I To determine the response rate partial response PR and complete response CR in patients with malignant mesothelioma treated with BAY 43-9006
SECONDARY OBJECTIVES
I To determine 3-month failure free survival in patients with malignant mesothelioma treated with BAY 43-9006
II To describe the median and overall survival of malignant mesothelioma patients treated with BAY 43-9006
III To describe the toxicity profile of BAY 43-9006 in patients with malignant mesothelioma
IV To determine whether mesotheliomas contain mutations in exons 11 and 15 of the B-raf gene and correlate these findings with anti-tumor activity of BAY 43-9006
V To determine whether the amount of expression of phospho-ERK12 as determined by immunohistochemistry from pre-treatment tumor specimens correlates with anti-tumor activity of BAY 43-9006 in patients with mesothelioma
VI To determine whether baseline levels and changes following BAY 43-9006 treatment in angiogenic cytokines VEGF and PDGF correlate with anti-tumor activity of BAY 43-9006
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at least every 2 months for 1 year every 4 months for 1 year and then every 6 months for 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| CALGB-30307 | None | None | None |
| CDR0000415372 | None | None | None |
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |