Trial Information

A Multicenter, Randomized, Double-blind, Parallel-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum-resistant and topotecan-and/or Liposomal Doxorubicin-resistant Advanced Ovarian Cancer

The study included:

- A screening period for 21 days

- Randomization at baseline (Treatment was initiated with 5 days of randomization)

- A treatment period with 14-day study treatment cycles until a study withdrawal
criterion was met

- A follow-up period up to 60 days after the end of treatment

Withdrawal criteria that led to treatment discontinuation were:

- The participant or their legally authorized representative requested to withdraw

- In the investigator's opinion, continuation of the study would be detrimental to the
participant's well being, due to reasons such as disease progression, unacceptable
toxicity, noncompliance, or logistical considerations.

- A specific request by the Sponsor

- Participant had intercurrent illness that prevented further administration of study
treatment

- Participant had more than 2 aflibercept dose reductions

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

- Participant had radiographic evidence of intestinal obstruction (e.g., dilated loops of
bowel accompanied by air-fluid levels) or gastrointestinal perforation (e.g., presence
of extraluminal gas) requiring surgical intervention

- Participant was lost to follow-up

After discontinuing treatment, participants remained on the study until the last
post-treatment visit or until recovery of drug related toxicities, whichever was later.