Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Ovarian Neoplasms, Ascites
In brief
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.
Key facts
- Study ID
- NCT00327444
- Run by
- Sanofi
- People needed
- 58
- Starts
- 2006-07-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2013-01-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Advanced ovarian epithelial cancer, treated with paracentesis
- Platinum-resistant, and topotecan-resistant and/or liposomal doxorubicin-resistant disease;
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
You may not qualify if…
- Pseudomyxoma peritonei or peritoneal mesothelioma;
- Transudative ascites;
- Peritoneovenous or other shunt placed for malignant ascites management;
- Recent (<6 months) cardiovascular event (pulmonary embolus, myocardial infarction, stroke) or gastrointestinal disease (ulcer, hepatic cirrhosis);
- Known brain metastases;
- Uncontrolled hypertension;
- Recent treatment with chemotherapy, surgery or radiotherapy;
- Prior treatment with VEGF or VEGFR inhibitor.
- 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 — Vienna, Austria
- Sanofi-Aventis Administrative Office — Diegem, Belgium
- Sanofi-Aventis Administrative Office — Laval, Canada
- Sanofi-Aventis Administrative Office — Budapest, Hungary
- Sanofi-Aventis Administrative Office — Mumbai, India
- Sanofi-Aventis Administrative Office — Netanya, Israel
- Sanofi-Aventis Administrative Office — Barcelona, Spain
- Sanofi-Aventis Administrative Office — Guildford Surrey, United Kingdom
Full record on ClinicalTrials.gov
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