Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00508001
Status:
COMPLETED
Last Update Posted:
2016-10-10
First Post:
2007-07-25
Brief Title:
Phase II Study of Best Support Care BSC Plus ZD6474Vandetanib in Patients With Inoperable Hepatocellular Carcinoma HCC
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Randomised Double-blind Parallel Group Multi-centre Phase II Study to Assess the Efficacy and Safety of Best Support Care BSC Plus ZD6474Vandetanib 300 mg BSC Plus ZD6474Vandetanib 100 mg and BSC Plus Placebo in Patients With Inoperable Hepatocellular Carcinoma HCC
Status:
COMPLETED
Status Verified Date:
2016-08
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 is a multi-centre phase II study to assess the efficacy and safety of ZD6474 in patients with Child-Pugh class A inoperable HCC This study comprises 2 phases the primary treatment phase and the secondary treatment phase The primary treatment phase is a randomised double-blind parallel-group phase II study to assess the efficacy and safety of ZD6474 300 mg plus best support care BSC ZD6474 100 mg plus BSC and placebo plus BSC The secondary treatment phase is an open-label expanded access program of ZD6474 In the primary treatment phase patients will be randomised in a 111 ratio to receive ZD6474 300 mg plus BSC ZD6474 100 mg plus BSC or placebo plus BSC respectively Randomisation will be stratified on the basis of Cancer of the Liver Italian Programme CLIP tumour staging CLIP score 0-2 versus 3-4 The primary treatment will continue until objective disease progression according to Response Evaluation Criteria in Solid Tumours RECIST criteria or until patients meet any other withdrawal or discontinuation criteriaThe primary endpoint is tumour stabilisation rate and the secondary endpoints are objective response rate progression-free survival and overall survival The purpose of the secondary treatment phase is to expand the access of ZD6474 so that every patient who is enrolled into this study can have the chance to receive the active medicineOnce an individual patient has progressive disease in the primary treatment phase the blind will be broken for this patient If this patient is in the ZD6474 100 mg arm or placebo arm the patient will be offered the secondary treatment with ZD6474 300 mg per day If this patient is randomised to the ZD6474 300 mg arm the study medication will be discontinued unless the patient wishes to remain the treatment and the patient is to be followed up for survival
Detailed Description:
None
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