NCT00327444|CompletedPhase 2ResultsDMC

Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

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

Sanofi ClinicalTrials.gov

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3 other identifiers

EFC6125EudraCT : 2005-005026-31AVE0005A /3001

Study Type

interventional

Target

Locations

9 countries

Sites

Timeline

RegisteredMay 2006

StartedJul 2006

CompletionOct 2009

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach

9 countries

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

First Submitted

Initial submission to the registry

May 16, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed

1 month until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed

3.3 years until next milestone

Results Posted

Study results publicly available

January 1, 2013

Completed

Last Updated

January 1, 2013

Status Verified

July 1, 2011

Enrollment Period

3.3 years

First QC Date

May 16, 2006

Results QC Date

August 17, 2012

Last Update Submit

November 30, 2012

Conditions

Ovarian Neoplasms Ascites

Keywords

Ovarian neoplasmAscitesAngiogenesis inhibitorVascular Endothelial Growth Factor ARecombinant fusion protein

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Area Under the Curve (AUC) for Participant Assessed Ascites Impact Measure (AIM)
From Day 1 up to 60 days from randomization to the first postrandomization paracentesis
60-Day Frequency of Paracentesis (FOP)
From Day 1 up to 60 days from randomization
Plasma Levels of Free and VEGF-bound Aflibercept
Following every biweekly treatment administration up to 60 days after treatment discontinuation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants with advanced ovarian cancer administered placebo in the double-blind (DB) period. In the open-label (OL) period, participants had the option to receive aflibercept or be withdrawn from the study.

Drug: PlaceboDrug: aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

Aflibercept

EXPERIMENTAL

Participants with advanced ovarian cancer administered aflibercept in the double-blind (DB) period. In the open-label (OL) period, participants had the option to continue to receive aflibercept or be withdrawn from the study.

Drug: aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

Interventions

aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)DRUG

4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.

Aflibercept

PlaceboDRUG

Placebo was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.

Placebo

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Advanced ovarian epithelial cancer, treated with paracentesis
Platinum-resistant, and topotecan-resistant and/or liposomal doxorubicin-resistant disease;
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2.

You may not qualify if:

Pseudomyxoma peritonei or peritoneal mesothelioma;
Transudative ascites;
Peritoneovenous or other shunt placed for malignant ascites management;
Recent (\<6 months) cardiovascular event (pulmonary embolus, myocardial infarction, stroke) or gastrointestinal disease (ulcer, hepatic cirrhosis);
Known brain metastases;
Uncontrolled hypertension;
Recent treatment with chemotherapy, surgery or radiotherapy;
Prior treatment with VEGF or VEGFR inhibitor.
The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Contact the study team to confirm eligibility.