Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044512
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2002-08-30
Brief Title:
A Study to Estimate Safety and Efficacy of Sorafenib BAY43-9006 in the Treatment of Hepatocellular Carcinoma
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase II Multicenter Uncontrolled Trial of Sorafenib BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-03
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:
Evaluate anti-cancer activity eg proportion of patients with confirmed complete response or partial response in patients with advanced inoperable biopsy-proven hepatocellular carcinoma
Detailed Description:
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations
Pharmacokinetics PK profile of Sorafenib
Plasma and tissue tumor biomarkers
Pharmacokinetics PK profile of Sorafenib
Plasma and tissue tumor biomarkers
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