Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140478
Status:
COMPLETED
Last Update Posted:
2009-12-09
First Post:
2005-08-30
Brief Title:
Mifepristone RU-486 in Androgen Independent Prostate Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Mifepristone RU-486 in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
Status:
COMPLETED
Status Verified Date:
2009-12
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:
The purpose of this study is to determine the effects good and bad that mifepristone has on patients with androgen independent prostate cancer
Detailed Description:
Patients will receive mifepristone 200mg orally once a day One treatment cycle is 28 days long Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects
At the end of each cycle a physical examination routine blood tests and hormone levels will be performed
After every 3 cycles one or more of the following will be performed bone scan chest x-ray CT scan or MRI
At the end of each cycle a physical examination routine blood tests and hormone levels will be performed
After every 3 cycles one or more of the following will be performed bone scan chest x-ray CT scan or MRI
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