Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287222
Status:
COMPLETED
Last Update Posted:
2011-07-15
First Post:
2006-02-03
Brief Title:
Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The primary efficacy endpoint will be the proportion of subjects that remain free of progression at the 27th week following the onset of treatment Secondary objectives include the subjects time in weeks from treatment onset to documented disease progression as assessed by the RECIST criteria response rate median and overall survival safety and tolerability
Detailed Description:
This is a phase II study to assess the proportion of subjects that remain progression-free by the 27th week following the onset of treatment and to assess the efficacy of the combination of Bevacizumab and Erlotinib in prolonging time to progression in subjects with inoperable and metastatic hepatocellular carcinoma Subjects will be treated with a combination of rhuMAb VEGF Bevacizumab in combination with Erlotinib and TTP will be assessed as per RECIST criteria The disease will be evaluated at base line and every 9 weeks with CT scanMRI and AFP levels Subjects will be kept on the study till disease progression as defined by RECIST criteria or death
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