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

NCT00327444 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2013-01-01

Study results available
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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.

Conditions

  • Ovarian Neoplasms
  • Ascites

Interventions

DRUG

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

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

DRUG

Placebo

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

DRUG

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

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

Sponsors & Collaborators

Principal Investigators

  • Walter GOTLIEB · Director of Gynecologic Oncology and Colposcopy Associate Professor of Oncology, McGill University - Montreal - Quebec Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Hungary
  • India
  • Israel
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00327444 on ClinicalTrials.gov