Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00874874
Status:
UNKNOWN
Last Update Posted:
2009-12-24
First Post:
2009-04-02
Brief Title:
Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced Metastatic or Unable to Be Removed by Surgery
Sponsor:
Centre Oscar Lambret
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
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 angiosarcoma that is locally advanced metastatic or unable to be removed by surgery
PURPOSE This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced metastatic or unable to be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the rate of non-progression at 9 months in patients with unresectable locally advanced or metastatic angiosarcoma treated with sorafenib tosylate
Secondary
Determine the rate of non-progression at 60 120 and 180 days
Determine the median time to progression
Determine overall survival
Determine the best response rate
Determine the clinical and biological factors that predict clinical benefit
Evaluate tolerability by NCI CTCAE v30
Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis
Explore the tumor expression of these genes in tissue from a tumor bank
OUTLINE This is a multicenter study
Patients are stratified according to disease type cutaneous angiosarcoma scalp breast or soft tissue vs visceral angiosarcoma All patients receive oral sorafenib tosylate twice daily for 9 months in the absence of disease progression or unacceptable toxicity
Primary
Determine the rate of non-progression at 9 months in patients with unresectable locally advanced or metastatic angiosarcoma treated with sorafenib tosylate
Secondary
Determine the rate of non-progression at 60 120 and 180 days
Determine the median time to progression
Determine overall survival
Determine the best response rate
Determine the clinical and biological factors that predict clinical benefit
Evaluate tolerability by NCI CTCAE v30
Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis
Explore the tumor expression of these genes in tissue from a tumor bank
OUTLINE This is a multicenter study
Patients are stratified according to disease type cutaneous angiosarcoma scalp breast or soft tissue vs visceral angiosarcoma All patients receive oral sorafenib tosylate twice daily for 9 months in the absence of disease progression or unacceptable toxicity
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2007-004651-10 | None | None | None |
| COL-Angio-Next | None | None | None |
| BAYER-COL-Angio-Next | None | None | None |
| COL-2007-10 | None | None | None |
| INCA-RECF0636 | None | None | None |