Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer
Neoplasms, Cancer of the Ovary
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring ovarian cancer, angiogenesis, angiogenesis inhibition, VEGF-Trap fusion recombinant protein, Cancer and other neoplasms
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Aflibercept 2.0 mg/kg
Aflibercept 4.0 mg/kg
Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept.
Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept.