Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238121
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2005-10-12
Brief Title:
Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of BAY 43-9006 in AdvancedRecurrent Uterine CarcinomaCarcinosarcoma
Status:
COMPLETED
Status Verified Date:
2014-01
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:
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 This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective response rate in patients with advanced or recurrent uterine cancer treated with sorafenib
II Determine the toxic effects of this drug in these patients
SECONDARY OBJECTIVES
I Determine progression-free survival of patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to histology carcinoma vs carcinosarcoma
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
I Determine the objective response rate in patients with advanced or recurrent uterine cancer treated with sorafenib
II Determine the toxic effects of this drug in these patients
SECONDARY OBJECTIVES
I Determine progression-free survival of patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to histology carcinoma vs carcinosarcoma
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62203 | NIH | None | httpsreporternihgovquickSearchN01CM62203 |
| 13572A | None | None | None |
| CDR0000445181 | None | None | None |