Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519285
Status:
COMPLETED
Last Update Posted:
2016-07-22
First Post:
2007-08-21
Brief Title:
Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel Prednisone for Metastatic Androgen-independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
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:
VENICE
Brief Summary:
Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel prednisone for metastatic androgen-independent prostate cancer MAIPC
The secondary objectives were
To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen PSA level cancer related pain progression free survival PFS tumor-based and skeletal events and health-related quality of life HRQL
To assess the overall safety in both treatment arms
To determine the pharmacokinetics of intravenous IV aflibercept in this population
to determine immunogenicity of IV aflibercept
The secondary objectives were
To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen PSA level cancer related pain progression free survival PFS tumor-based and skeletal events and health-related quality of life HRQL
To assess the overall safety in both treatment arms
To determine the pharmacokinetics of intravenous IV aflibercept in this population
to determine immunogenicity of IV aflibercept
Detailed Description:
The study consisted in 3-week treatment cycles until progressive disease unacceptable toxicity or participants refusal of further study treatment After disease progression participants were to be followed every 3 months until death or the study cutoff date whichever came first
The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred
The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-004756-20 | EUDRACT_NUMBER | None | None |