CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)drug
Likely dose
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00396591
NCT00396591Phase 2Completed
CompareCT.gov

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

Sanofi·interventional·Posted Nov 7, 2006·Updated Jan 10, 2013

In Brief

A Phase 2 clinical trial evaluating Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) for Ovarian Neoplasms. Completed, enrolled 16 participants across 3 sites in 3 countries.

Detailed Summary

The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites. The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasms
CountriesItaly, Sweden, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2006
Enrollment StartOct 1, 2006
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.7 years ago

Interventions

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)drug

4.0 mg/kg administered intravenously (IV) once every 2 weeks