Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516165
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2007-08-13
Brief Title:
RAD001 in Advanced Hepatocellular Carcinoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase III Study of RAD001 in Advanced Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
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:
Laboratory studies have shown that RAD001 can prevent cells from multiplying Consequently the study drug is being tested in medical conditions in which excessive cell multiplication as in cancer needs to be stopped The main purpose of this research study is to find the highest dose of RAD001 that can be given safely without causing severe side effects and to learn the effects good or bad RAD001 has on participants with liver cancer
Detailed Description:
Participants will be given a supply of the study drug RAD001 to be taken at home They will be asked to take the study drug every morning on an empty stomach and will be given a study drug diary to record the timedate each time they take RAD001 Each 6 week period of time is called a cycle of study treatment
We are looking for the highest dose of RAD001 that can be given safely Therefore not every participant will receive the same dose of RAD001
Participants will come to the clinic every other week At each of these visits a physical examination and blood tests will be performed
A CT and MRI will be repeated every 6 weeks during the first 3 cycles of treatment then every 12 weeks thereafter
We are looking for the highest dose of RAD001 that can be given safely Therefore not every participant will receive the same dose of RAD001
Participants will come to the clinic every other week At each of these visits a physical examination and blood tests will be performed
A CT and MRI will be repeated every 6 weeks during the first 3 cycles of treatment then every 12 weeks thereafter
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