Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427973
Status:
TERMINATED
Last Update Posted:
2016-10-31
First Post:
2007-01-25
Brief Title:
AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of AZD2171 in Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped prior to 2nd stage
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 AZD2171 works in treating patients with locally advanced unresectable or metastatic liver cancer AZD2171 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 OBJECTIVE
I Assess the progression free survival of patients with locally advanced unresectable or metastatic hepatocellular carcinoma treated with AZD2171
SECONDARY OBJECTIVES
I Determine the toxicity of this drug in these patients II Determine preliminarily the efficacy of this drug in terms of response rate duration of response and overall survival in these patients
III Determine the blood flow changes and vascular permeability of the tumor in patients treated with this drug
IV Determine the pharmacokinetic profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral AZD2171 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Dynamic contrast-enhanced DCE MRI and CT perfusion scan of the liver are performed at baseline 72 hours after the initial dose of AZD2171 and at the end of course 1 Blood samples for pharmacokinetic studies are collected periodically during study
After the completion of study treatment patients are followed every 3 months for 1 year
I Assess the progression free survival of patients with locally advanced unresectable or metastatic hepatocellular carcinoma treated with AZD2171
SECONDARY OBJECTIVES
I Determine the toxicity of this drug in these patients II Determine preliminarily the efficacy of this drug in terms of response rate duration of response and overall survival in these patients
III Determine the blood flow changes and vascular permeability of the tumor in patients treated with this drug
IV Determine the pharmacokinetic profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral AZD2171 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Dynamic contrast-enhanced DCE MRI and CT perfusion scan of the liver are performed at baseline 72 hours after the initial dose of AZD2171 and at the end of course 1 Blood samples for pharmacokinetic studies are collected periodically during study
After the completion of study treatment patients are followed every 3 months for 1 year
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 |
|---|---|---|---|
| CDR0000526405 | REGISTRY | PDQ Physician Data Query | None |
| 05-311 | OTHER | None | None |
| N02CO12400 | OTHER_GRANT | None | None |