Status:
COMPLETED
AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer partic...
Detailed Description
The study consisted of: * A 30-day screening phase prior to Day 1 * Day 1 registration and pre-treatment paracentesis * Aflibercept administration within 1-day of registration * Two-week study treatm...
Eligibility Criteria
Inclusion
- Participants that met the following criteria were eligible.
- Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that required at least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per month for management.
- Platinum resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
- Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
Exclusion
- Peritoneovenous or other type of shunt that was placed for the management of ascites
- Prior treatment with a VEGF or VEGF receptor inhibitor
- Uncontrolled hypertension
- The above information is not intended to contain all considerations relevant to participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00396591
Start Date
October 1 2006
End Date
November 1 2008
Last Update
January 10 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Milan, Italy
3
Sanofi-Aventis Administrative Office
Bromma, Sweden