Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00327444
Status:
COMPLETED
Last Update Posted:
2013-01-01
First Post:
2006-05-16
Brief Title:
Study of the Effect of Intravenous AVE0005 VEGF Trap in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Parallel-arm Study of the Effect of Intravenous Aflibercept Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Status:
COMPLETED
Status Verified Date:
2011-07
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:
This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer
Primary objective Compare the effect of aflibercept ziv-aflibercept AVE0005 VEGF trap ZALTRAP to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer
Secondary objectives Safety tolerability paracentesis-related parameters participant-reported outcome
Primary objective Compare the effect of aflibercept ziv-aflibercept AVE0005 VEGF trap ZALTRAP to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer
Secondary objectives Safety tolerability paracentesis-related parameters participant-reported outcome
Detailed Description:
The study included
A Thirty 30-day screening phase
The double blind treatment period for a minimum of 60 days Day 1 of the double-blind treatment period was defined as the date of the qualifying paracentesis ie withdrawal of 1 Liter of ascitic fluid Participants were randomized after adequate recovery from the qualifying paracentesis The first dose was administered on Day 1 or Day 2
The optional open-label extension until treatment discontinuation criteria were met
A posttreatment follow-up phase lasting 60 days
Criteria for discontinuation included
1 Participant or his legally authorized representative request discontinuation
2 In the Investigators opinion continuation of treatment would be detrimental to the participants well being such as disease progression unacceptable toxicity noncompliance or logistical considerations
3 Sponsor request
4 Intercurrent illness that prevented further administration of investigational productIP
5 More than 2 IP dose reductions
6 Unacceptable adverse events AE not manageable by symptomatic therapy dose delay or dose modification
7 Arterial thromboembolic events including cerebrovascular accidents myocardial infarctions transient ischemic attacks new onset or worsening of preexisting angina
8 Radiographic evidence of intestinal obstruction for example dilated loops of bowel accompanied by air-fluid levels or gastrointestinal perforation for example presence of extraluminal gas requiring surgical intervention
A Thirty 30-day screening phase
The double blind treatment period for a minimum of 60 days Day 1 of the double-blind treatment period was defined as the date of the qualifying paracentesis ie withdrawal of 1 Liter of ascitic fluid Participants were randomized after adequate recovery from the qualifying paracentesis The first dose was administered on Day 1 or Day 2
The optional open-label extension until treatment discontinuation criteria were met
A posttreatment follow-up phase lasting 60 days
Criteria for discontinuation included
1 Participant or his legally authorized representative request discontinuation
2 In the Investigators opinion continuation of treatment would be detrimental to the participants well being such as disease progression unacceptable toxicity noncompliance or logistical considerations
3 Sponsor request
4 Intercurrent illness that prevented further administration of investigational productIP
5 More than 2 IP dose reductions
6 Unacceptable adverse events AE not manageable by symptomatic therapy dose delay or dose modification
7 Arterial thromboembolic events including cerebrovascular accidents myocardial infarctions transient ischemic attacks new onset or worsening of preexisting angina
8 Radiographic evidence of intestinal obstruction for example dilated loops of bowel accompanied by air-fluid levels or gastrointestinal perforation for example presence of extraluminal gas requiring surgical intervention
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 |
|---|---|---|---|
| AVE0005A 3001 | None | None | None |
| EudraCT 2005-005026-31 | None | None | None |