A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Effect of Intravenous Aflibercept Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
The study included:
- A Thirty (30)-day screening phase
- The double blind treatment period for a minimum of 60 days. Day 1 of the double-blind
treatment period was defined as the date of the qualifying paracentesis (ie, withdrawal
of >= 1 Liter of ascitic fluid). Participants were randomized after adequate recovery
from the qualifying paracentesis (The first dose was administered on Day 1 or Day 2).
- The optional open-label extension (until treatment discontinuation criteria were met)
- A posttreatment follow-up phase lasting 60 days.
Criteria for discontinuation included:
1. Participant or his legally authorized representative request discontinuation
2. In the Investigator's opinion, continuation of treatment would be detrimental to the
participant's well being, such as disease progression, unacceptable toxicity,
noncompliance, or logistical considerations
3. Sponsor request
4. Intercurrent illness that prevented further administration of investigational
5. More than 2 IP dose reductions
6. Unacceptable adverse events (AE) not manageable by symptomatic therapy, dose delay, or
7. Arterial thromboembolic events, including cerebrovascular accidents, myocardial
infarctions, transient ischemic attacks, new onset or worsening of preexisting angina
8. Radiographic evidence of intestinal obstruction (for example, dilated loops of bowel
accompanied by air-fluid levels) or gastrointestinal perforation (for example, presence
of extraluminal gas) requiring surgical intervention
Participants who met the following criteria were eligible to participate in this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time to Repeat Paracentesis (TRP)
TRP was defined as the number of days between the date of randomization and the date of the first post-randomization paracentesis. For participants who did not undergo a postrandomization paracentesis on study, TRP was calculated from randomization to the end of the double-blind treatment period.
From Day 1 up to 6 months from randomization
Director of Gynecologic Oncology and Colposcopy Associate Professor of Oncology, McGill University - Montreal - Quebec Canada
United States: Food and Drug Administration
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