Status:
COMPLETED
Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Neoplasms
Cancer of the Ovary
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 (z...
Detailed Description
The study included: * A screening period for 21 days * Randomization at baseline (Treatment was initiated with 5 days of randomization) * A treatment period with 14-day study treatment cycles until a...
Eligibility Criteria
Inclusion
- Participants who met the following criteria were eligible for the study.
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00327171
Start Date
May 1 2006
End Date
March 1 2010
Last Update
June 7 2016
Active Locations (11)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
3
Sanofi-Aventis Administrative Office
Laval, Canada
4
Sanofi-Aventis Administrative Office
Paris, France