Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT00044512
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2002-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Sponsor:
Bayer
Organization:
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 (e.g. 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:
False
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?: