Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247676
Status:
COMPLETED
Last Update Posted:
2010-02-18
First Post:
2005-11-01
Brief Title:
An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-02
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 study will consist of two parts In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients If the study gives good results it can be expanded to a total of 160 patients SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg milligrams with provision for dose reduction based on tolerability All patients will receive repeated cycles of SU011248 until disease progression occurrence of unacceptable toxicity or other withdrawal criteria are met After discontinuation of treatment patients will be followed up in order to collect information on further antineoplastic therapy and 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