At a glance
ClinicalIndex Comparison Record- ✓Advanced ovarian epithelial cancer treated with paracentesis
- ✓Platinum-resistant disease
- ✓Topotecan-resistant and/or liposomal doxorubicin-resistant disease
- ✓ECOG performance status 0, 1, or 2
- ✕Pseudomyxoma peritonei or peritoneal mesothelioma
- ✕Transudative ascites
- ✕Peritoneovenous or other shunt placed for malignant ascites
- ✕Recent (<6 months) cardiovascular event: pulmonary embolus, myocardial infarction, or stroke
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) and Placebo for Ovarian Neoplasms and Ascites. Completed, enrolled 58 participants across 9 sites in 9 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.
Placebo was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.
4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the OL period.