Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

Participants who met the following criteria were eligible for the study.

Inclusion Criteria:

• Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma.

• Prior treatment with at least 2 treatment regimens in the advanced disease treatment setting

• 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

• Evidence of at least one unidimensional measurable tumor lesion by computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) that has not been treated with surgery or radiation therapy

Exclusion Criteria:

• Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri

• Prior treatment with a vascular endothelial growth factor (VEGF) or VEGF receptor inhibitor

• More than 3 chemotherapy regimens in the advanced disease treatment setting

• Uncontrolled hypertension

The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.