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AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Biomarker/Laboratory analysis, Treatment Completed 18 and over Pharmaceutical / Industry ARD6772
EUDRACT: 2006-000604-16, NCT00396591

Trial Description

Summary

The primary objective of this study is to compare the time between paracenteses before and after administration of AVE0005 (VEGF Trap) in ovarian cancer patients with symptomatic malignant ascites. The secondary objectives are to further assess efficacy, safety, pharmacokinetics, immunogenicity and health-related quality of life.

Eligibility Criteria

Inclusion Criteria:

Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer.

Platinum resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.

Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.

Exclusion Criteria:

Peritoneovenous or other type of shunt that was placed for the management of ascites

Prior treatment with a VEGF or VEGF receptor inhibitor

Uncontrolled hypertension

The investigator will evaluate whether there are other reasons why a patient may not participate

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis - US - Bridgewater

Regeneron Pharmaceuticals

ICD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00396591
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.