Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174863
Status:
COMPLETED
Last Update Posted:
2008-12-23
First Post:
2005-09-13
Brief Title:
Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Evaluation of Two Doses of SR31747A 75 mg and 125 mg in Non-Metastatic Androgen-Independent Prostate Cancer Randomized Double-Blind Placebo Controlled Phase II Study
Status:
COMPLETED
Status Verified Date:
2008-12
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:
ODYSSEY
Brief Summary:
To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters Tumor response survival safetyTumor-related symptoms deterioration Quality of Life PK analysis as secondary objectives
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