Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131911
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2005-08-16
Brief Title:
Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2014-06
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 tosylate works in treating patients with progressive metastatic neuroendocrine tumors Sorafenib tosylate 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 objective tumor response rate of BAY 43-9006 sorafenib tosylate in patients with advanced neuroendocrine tumors
SECONDARY OBJECTIVES
I Adverse event rates II Progression free survival and time to progression III Improvement in circulating hormone levels IV Overall survival
OUTLINE This is a multicenter study Patients are grouped into 2 separate analysis Groups according to tumor type Group A Carcinoid Group B Islet cellother well-differentiated tumor Each Group was independently evaluated for all study endpoints
Patients receive oral sorafenib tosylate 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 every 3 months until disease progression and then every 6 months for up to 2 years from study entry
I To determine the objective tumor response rate of BAY 43-9006 sorafenib tosylate in patients with advanced neuroendocrine tumors
SECONDARY OBJECTIVES
I Adverse event rates II Progression free survival and time to progression III Improvement in circulating hormone levels IV Overall survival
OUTLINE This is a multicenter study Patients are grouped into 2 separate analysis Groups according to tumor type Group A Carcinoid Group B Islet cellother well-differentiated tumor Each Group was independently evaluated for all study endpoints
Patients receive oral sorafenib tosylate 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 every 3 months until disease progression and then every 6 months for up to 2 years from study entry
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 |
|---|---|---|---|
| N01CM62205 | NIH | None | httpsreporternihgovquickSearchN01CM62205 |
| MC044H | None | None | None |
| 7046 | None | None | None |
| CDR0000437792 | None | None | None |