Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082134
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2004-04-29
Brief Title:
Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II non-randomized open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel Approximately 40 patients will be enrolled in this study that is expected to last 24 months All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days The primary objective of this study is to determine the PSA response rate The secondary objectives are to determine response of measurable disease duration of response time to PSA progression time to treatment failure survival safety and tolerability and pharmacokinetic profile of ILX651
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