Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217620
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2005-09-20
Brief Title:
S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of BAY-9006 NSC 724772 in Advanced Soft Tissue Sarcomas
Status:
COMPLETED
Status Verified Date:
2013-01
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:
RATIONALE 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
PURPOSE This phase II trial is studying how well sorafenib works in treating patients with advanced soft tissue sarcomas
PURPOSE This phase II trial is studying how well sorafenib works in treating patients with advanced soft tissue sarcomas
Detailed Description:
OBJECTIVES
Determine the objective response rate confirmed complete and partial in patients with advanced soft tissue sarcomas treated with sorafenib
Determine the 4-month progression-free survival rate in patients treated with this drug
Determine the frequency and severity of adverse events in patients treated with this drug
OTHER OBJECTIVES if funding permits
Correlate preliminarily a decrease in standard uptake variable SUV of target lesions by positron-emission tomography scan at 4 weeks with response in patients treated with this drug
Correlate preliminarily the phosphorylation status of KIT PDGFR VEGFR and the rafmekerk pathway with response in patients treated with this drug
Correlate preliminarily the most common B-raf kinase mutation with response in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to histology leiomyosarcoma vs liposarcoma vs angiosarcoma hemangiosarcoma or hemangiopericytoma
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 every 8 weeks until disease progression and then every 6 months for 2 years and annually for up to 3 years
PROJECTED ACCRUAL A total of 45-75 patients 15-25 per stratum will be accrued for this study within 15-38 months
Determine the objective response rate confirmed complete and partial in patients with advanced soft tissue sarcomas treated with sorafenib
Determine the 4-month progression-free survival rate in patients treated with this drug
Determine the frequency and severity of adverse events in patients treated with this drug
OTHER OBJECTIVES if funding permits
Correlate preliminarily a decrease in standard uptake variable SUV of target lesions by positron-emission tomography scan at 4 weeks with response in patients treated with this drug
Correlate preliminarily the phosphorylation status of KIT PDGFR VEGFR and the rafmekerk pathway with response in patients treated with this drug
Correlate preliminarily the most common B-raf kinase mutation with response in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to histology leiomyosarcoma vs liposarcoma vs angiosarcoma hemangiosarcoma or hemangiopericytoma
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 every 8 weeks until disease progression and then every 6 months for 2 years and annually for up to 3 years
PROJECTED ACCRUAL A total of 45-75 patients 15-25 per stratum will be accrued for this study within 15-38 months
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 |
|---|---|---|---|
| S0505 | OTHER | None | None |
| U10CA032102 | NIH | None | None |
| CDR0000442404 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |