Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495625
Status:
TERMINATED
Last Update Posted:
2012-03-27
First Post:
2007-06-29
Brief Title:
Sunitinib Malate SUO11248 In Subjects W Metastatic AndOr Surgically Unresectable Hepatocellular Cancers HCC
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Open-Label Study of Sunitinib Malate SUO11248 in Adult Subjects With Metastatic andor Surgically Unresectable Hepatocellular Cancers HCC
Status:
TERMINATED
Status Verified Date:
2011-12
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:
An open label multi-site phase II clinical trial of dose escalated sunitinib malate given orally once daily on days 1-28 of each 42-day cycle Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment
Detailed Description:
An open label multi-site phase II clinical trial of sunitinib malate given orally once daily on days 1-28 of each 42-day cycle Sunitinib malate will be dispensed as capsules at the beginning of each treatment cycle The dose may be escalated at the investigators discretion Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment
A follow up visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination Complete blood count CBC and differential comprehensive metabolic panel including liver function tests and alpha-feto protein when indicated will be obtained at every scheduled follow up visit
A follow up visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination Complete blood count CBC and differential comprehensive metabolic panel including liver function tests and alpha-feto protein when indicated will be obtained at every scheduled follow up visit
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 |
|---|---|---|---|
| Pfizer 2005-0880 | OTHER | Pfizer | None |