Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112671
Status:
COMPLETED
Last Update Posted:
2018-07-27
First Post:
2005-06-02
Brief Title:
Sorafenib in Treating Patients With Advanced or Metastatic Cancer of the Urinary Tract
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of BAY 43-9006 in Advanced or Metastatic Urothelial Cancer Transitional Cell Cancer of the Bladder Ureter and Renal Pelvis
Status:
COMPLETED
Status Verified Date:
2018-07
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 or metastatic cancer of the urinary tract 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:
PRIMARY OBJECTIVES
I To assess the efficacy response rate and stable disease rate of Bay 439006 given to patients with advanced or metastatic urothelial cancer
II To assess the toxicity time to progression and response duration of Bay 439006 given to patients with advanced or metastatic urothelial cancer
III To measure Ras mutational status and EGFRHER2 on archival specimens To determine baseline and post-treatment levels of pERK pAKT VEGFR2 CD31 Ki-67MIB-1 and cleaved caspase 3 and to explore the relationship between these correlative endpoints and clinical outcome
OUTLINE This is a nonrandomized open-label 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 within 3 weeks and then every 3 months thereafter
I To assess the efficacy response rate and stable disease rate of Bay 439006 given to patients with advanced or metastatic urothelial cancer
II To assess the toxicity time to progression and response duration of Bay 439006 given to patients with advanced or metastatic urothelial cancer
III To measure Ras mutational status and EGFRHER2 on archival specimens To determine baseline and post-treatment levels of pERK pAKT VEGFR2 CD31 Ki-67MIB-1 and cleaved caspase 3 and to explore the relationship between these correlative endpoints and clinical outcome
OUTLINE This is a nonrandomized open-label 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 within 3 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| N01CM62203 | NIH | None | httpsreporternihgovquickSearchN01CM62203 |
| PHL-036 | None | None | None |
| 7062 | None | None | None |