Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126568
Status:
TERMINATED
Last Update Posted:
2018-01-19
First Post:
2005-08-02
Brief Title:
Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid
Status:
TERMINATED
Status Verified Date:
2017-12
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 advanced anaplastic thyroid cancer 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:
OBJECTIVES
I Determine whether the objective response rate is 20 in patients with advanced anaplastic thyroid cancer treated with sorafenib
II Determine the survival of patients treated with this drug III Determine the safety profile of this drug in these patients IV Determine the pharmacokinetic predictors of response to this drug in these patients
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 for survival
I Determine whether the objective response rate is 20 in patients with advanced anaplastic thyroid cancer treated with sorafenib
II Determine the survival of patients treated with this drug III Determine the safety profile of this drug in these patients IV Determine the pharmacokinetic predictors of response to this drug in these patients
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 for survival
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 |
|---|---|---|---|
| U01CA062502 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062502 |
| NCI-2009-00118 | REGISTRY | None | None |
| CASE 5304 | None | None | None |
| CDR0000437789 | None | None | None |
| CASE 5304 | OTHER | None | None |
| 7037 | OTHER | None | None |