Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma
receiving aflibercept.
The primary objective was to compare the objective response rate of Aflibercept
(ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered
intravenously (IV) every 2 weeks with historical control in participants with advanced
ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant
to platinum and topotecan and/or liposomal doxorubicin.
The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential
biological and pharmacogenomic markers of study drug activity, and health-related quality of
life.
This study employed an Independent Review Committee (IRC) for radiological tumor assessments.
For all tumor assessment-related efficacy variables, two analyses were performed: the primary
analysis was based on Independent Review Committee (IRC) reviewed data and the secondary
analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the
IRC reviewed data is reported for this study.