AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites
Completed · Phase 2
Conditions studied: Ovarian Neoplasms
In brief
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 participants with symptomatic malignant ascites. The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.
Key facts
- Study ID
- NCT00396591
- Run by
- Sanofi
- People needed
- 16
- Starts
- 2006-10-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2013-01-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — Milan, Italy
- Sanofi-Aventis Administrative Office — Bromma, Sweden
Full record on ClinicalTrials.gov
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