multicenter, randomized, double-blind, parallel-arm, two-stage study of the efficacy and safety of AVE0005 VEGF Trap administered intravenously every 2 weeks in patients with platinum-resistant and topotecan- and/or liposomal doxorubicin-resistant advanced ovarian cancer - ND

• Conditions: patients with platinum-resistant and topotecan- and/or liposomal doxorubicin-resistant advanced ovarian cancer; MedDRA version: 6.1Level: PTClassification code 10061328

• Registration Number: EUCTR2005-005024-14-IT
• Lead Sponsor: Sanofi-Synthelabo Recherche, a subsidiary of sanofi-aventis group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-03
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

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 unidimensionally measurable tumor lesion by CT or MRI scan according to Response Evaluation Criteria in Solid Tumors RECIST that has not been treated with surgery or radiation therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 VEGF or VEGF receptor inhibitor More than 3 chemotherapy regimens in the advanced disease treatment setting Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks 6 weeks for nitrosoureas, mitomycin C, immunotherapy, or cytokine therapy of study enrollment. Uncontrolled hypertension, defined as blood pressure 150/100 mm Hg NCI CTCAE v.3.0 grade 8805;2 , or systolic blood pressure 180 mm Hg if diastolic blood pressure 90 mm Hg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified