Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238212
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2005-10-12
Brief Title:
S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of BAY 43-9006 NSC 724772 as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma
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:
This phase II trial is studying how well sorafenib works in treating patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma 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 objective response probability complete responses and partial responses for BAY 43-9006 in patients with unresectable or metastatic gallbladder or cholangiocarcinoma
II To assess overall survival time to treatment failure and progression-free survival in these patients
III To assess quantitative and qualitative toxicities of this regimen IV To evaluate in a preliminary fashion relevant prognostic and predictive molecular markers of clinical outcome in gallbladder and cholangiocarcinoma
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
After completion of study treatment patients are followed every 6 months for 3 years
I To assess the objective response probability complete responses and partial responses for BAY 43-9006 in patients with unresectable or metastatic gallbladder or cholangiocarcinoma
II To assess overall survival time to treatment failure and progression-free survival in these patients
III To assess quantitative and qualitative toxicities of this regimen IV To evaluate in a preliminary fashion relevant prognostic and predictive molecular markers of clinical outcome in gallbladder and cholangiocarcinoma
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
After completion of study treatment patients are followed every 6 months for 3 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 |
|---|---|---|---|
| CDR0000444959 | REGISTRY | PDQ Physician Data Query | None |
| S0514 | None | None | None |
| U01CA32102 | OTHER_GRANT | None | None |