Overview

AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
Female
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, ZALTRAPĀ®) 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Treatments:
Aflibercept
Criteria
Participants that met the following criteria were eligible.

Inclusion Criteria:

- 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 Criteria:

- 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.