Trial Information

A Multicenter, Open-label, Single-arm Study of the Efficacy and Safety of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

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 treatment cycles (for efficacy data, the cut-off date was 6 months
post-registration

- A 60-day post-treatment follow-up phase

During the study, participants were treated with Aflibercept study treatment through the
duration of the study unless they met one the following criteria for discontinuation:

- Participant (or legal representative) chose to withdraw from treatment

- The investigator or sponsor thought that continuation of the study would be detrimental
to the participants well-being

- Participant had intercurrent illness that prevented further administration of
investigational product (IP)

- Participant had more than 2 IP dose reductions

- Participant had unacceptable adverse events (AEs)

- Participant had arterial thromboembolic events, including cerebrovascular accidents,
myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of
preexisting angina

- Participant required surgical intervention for intestinal obstruction or
gastrointestinal perforation