Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095693
Status:
TERMINATED
Last Update Posted:
2014-01-16
First Post:
2004-11-05
Brief Title:
Sorafenib Tosylate in Treating Patients With Locally Advanced Metastatic or Locally Recurrent Thyroid Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma
Status:
TERMINATED
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:
Phase II trial to study the effectiveness of sorafenib tosylate in treating patients who have locally advanced metastatic or locally recurrent thyroid cancer Sorafenib tosylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine objective response rate in patients with locally advanced metastatic or locally recurrent differentiated thyroid cancer treated with sorafenib BAY 43-9006
SECONDARY OBJECTIVES
I Determine the toxicity of this drug in these patients II Correlate thyroglobulin levels with tumor response in patients treated with this drug
III Correlate fludeoxyglucose F 18 positron emission tomography results with tumor response in patients treated with this drug
IV Correlate tumor permeability and vascularity as determined by dynamic contrast-enhanced MRI with tumor response in patients treated with this drug
V Determine the pharmacodynamics of this drug in these patients VI Correlate the presence and type of B-raf N-ras or RETPTC gene mutations with clinical response in patients treated with this drug
VII Correlate the degree of Ras-MAPK signaling inhibition and vascular endothelial growth factor expression with clinical response in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to diagnosis papillary thyroid cancer that is chemo-naïve vs all others
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity Patients achieving complete remission CR receive 8 additional weeks of therapy beyond CR
Patients are followed within 2-4 weeks after completion of study treatment
I Determine objective response rate in patients with locally advanced metastatic or locally recurrent differentiated thyroid cancer treated with sorafenib BAY 43-9006
SECONDARY OBJECTIVES
I Determine the toxicity of this drug in these patients II Correlate thyroglobulin levels with tumor response in patients treated with this drug
III Correlate fludeoxyglucose F 18 positron emission tomography results with tumor response in patients treated with this drug
IV Correlate tumor permeability and vascularity as determined by dynamic contrast-enhanced MRI with tumor response in patients treated with this drug
V Determine the pharmacodynamics of this drug in these patients VI Correlate the presence and type of B-raf N-ras or RETPTC gene mutations with clinical response in patients treated with this drug
VII Correlate the degree of Ras-MAPK signaling inhibition and vascular endothelial growth factor expression with clinical response in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to diagnosis papillary thyroid cancer that is chemo-naïve vs all others
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity Patients achieving complete remission CR receive 8 additional weeks of therapy beyond CR
Patients are followed within 2-4 weeks after completion of study treatment
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 |
|---|---|---|---|
| NCI-2012-01457 | REGISTRY | None | None |
| OSU-0441 | None | None | None |
| CDR0000393968 | None | None | None |
| NCI-6608 | None | None | None |
| OSU-2004C0068 | None | None | None |
| OSU 0441 | OTHER | None | None |
| 6608 | OTHER | None | None |
| N01CM62207 | NIH | None | None |
| P30CA016058 | NIH | None | None |
| N01CM62206 | NIH | None | None |
| U01CA076576 | NIH | CTEP | httpsreporternihgovquickSearchU01CA076576 |