Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361309
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2006-08-04
Brief Title:
SU011248 in Advanced Hepatocellular Carcinoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-03
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 main purpose of this study is to begin to collect information and try to learn whether SU011248 works in treating patients with advanced liver cancer Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors which may prevent tumors from growing any further
Detailed Description:
Participants will be given a supply of SU011248 capsules to be taken orally every morning for 4 weeks After taking SU011248 for 4 weeks there will be a 2 week rest period when the participant will not take any capsules This 6-week period is referred to as 1 cycle
Participants will continue to receive SU011248 study treatment as long as their disease does not worsen significantly and they are not experiencing any serious side effects
During cycle 1 of study treatment the participant will come to the outpatient clinic once a week for blood work physical examination and dynamic contrast enhanced magnetic resonance imaging DCE-MRI which is done two weeks after they start taking study treatment
During cycle two and every cycle thereafter the participant will be asked to come to the outpatient clinic once every two weeks for physical examination blood work and urine tests
A CT scan or MRI scan to assess the tumor will be performed once during each cycle for the first three cycles then once every 2 cycles thereafter ACTH stimulation test will be done every 2 cycles A MUGA scan may be done at anytime at the discretion of the the study doctor
Participants will continue to receive SU011248 study treatment as long as their disease does not worsen significantly and they are not experiencing any serious side effects
During cycle 1 of study treatment the participant will come to the outpatient clinic once a week for blood work physical examination and dynamic contrast enhanced magnetic resonance imaging DCE-MRI which is done two weeks after they start taking study treatment
During cycle two and every cycle thereafter the participant will be asked to come to the outpatient clinic once every two weeks for physical examination blood work and urine tests
A CT scan or MRI scan to assess the tumor will be performed once during each cycle for the first three cycles then once every 2 cycles thereafter ACTH stimulation test will be done every 2 cycles A MUGA scan may be done at anytime at the discretion of the the study doctor
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