Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098540
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2004-12-07
Brief Title:
Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 stage IIIB or stage IV non-small cell lung cancer Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer treated with sorafenib
II Determine the clinical toxic effects of this drug in these patients
SECONDARY OBJECTIVES
I Determine the 24-week progression-free survival rate in patients treated with this drug
II Determine the overall survival of patients treated with this drug III Determine the time to disease progression in patients treated with this drug
IV Correlate predictive disease markers K-ras and B-raf mutations and ERKpERK AKTpAKT and VEGFR2p-VEGFR2 expression in these patients with the activity of this drug
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
Patients are followed every 6 months for up to 5 years
I Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer treated with sorafenib
II Determine the clinical toxic effects of this drug in these patients
SECONDARY OBJECTIVES
I Determine the 24-week progression-free survival rate in patients treated with this drug
II Determine the overall survival of patients treated with this drug III Determine the time to disease progression in patients treated with this drug
IV Correlate predictive disease markers K-ras and B-raf mutations and ERKpERK AKTpAKT and VEGFR2p-VEGFR2 expression in these patients with the activity of this drug
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
Patients are followed every 6 months for up to 5 years
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 |
|---|---|---|---|
| N0326 | None | None | None |
| NCCTG-N0326 | None | None | None |
| CDR0000398203 | None | None | None |
| U10CA025224 | NIH | None | httpsreporternihgovquickSearchU10CA025224 |