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Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer
This study has been completed.
First Received: May 16, 2006   Last Updated: June 5, 2008   History of Changes
Sponsors and Collaborators: Sanofi-Aventis
Regeneron Pharmaceuticals
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00327171
  Purpose

The primary objective is to compare the objective response rate of AVE0005 (VEGF Trap) 4.0 mg/kg and 2.0 mg/kg intravenous (IV) every 2 weeks with historical control in patients with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin.

The secondary objectives are to further assess efficacy, safety, pharmacokinetics, immunogenicity, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life.


Condition Intervention Phase
Neoplasms
Cancer of the Ovary
 Drug: AVE0005 (VEGF Trap)
 Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Aflibercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Multicenter, Randomized, Double-Blind, Parallel-Arm, Study of the Efficacy and Safety of AVE0005 Administered IV Every 2 Weeks in Patients With Platinum-Resistant and Topotecan and/or Liposomal Doxorubicin-Resistant Advanced Ovarian Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Objective response rate

Secondary Outcome Measures:
  • Clinical benefit response
  • Duration of response (DR)
  • Tumor marker response rate
  • Time to tumor progression
  • Time to tumor marker progression
  • Progression-free survival
  • Overall survival
  • Safety

Estimated Enrollment: 200
Study Start Date: June 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327171

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Australia
Sanofi-Aventis
Macquarie Park, Australia
Canada
Sanofi-Aventis
Laval, Canada
France
Sanofi-Aventis
Paris, France
Germany
Sanofi-Aventis
Berlin, Germany
Italy
Sanofi-Aventis
Milano, Italy
Netherlands
Sanofi-Aventis
Gouda, Netherlands
Portugal
Sanofi-Aventis
Porto Salvo, Portugal
Spain
Sanofi-Aventis
Barcelona, Spain
Sweden
Sanofi-Aventis
Bromma, Sweden
Switzerland
Sanofi-Aventis
Geneva, Switzerland
Sponsors and Collaborators
Sanofi-Aventis
Regeneron Pharmaceuticals
Investigators
Study Director: ICD CSD Sanofi-Aventis
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: sanofi-aventis ( ICD )
Study ID Numbers: ARD6122, AVE0005
Study First Received: May 16, 2006
Last Updated: June 5, 2008
ClinicalTrials.gov Identifier: NCT00327171     History of Changes
Health Authority: United States: Food and Drug Administration;   Spain: Ministry of Health;   Sweden: Medical Products Agency

Keywords provided by Sanofi-Aventis:
ovarian cancer
angiogenesis
angiogenesis inhibition
VEGF-Trap fusion recombinant protein
Cancer and other neoplasms

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer
Endocrine System Diseases
 Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Topotecan
Doxorubicin
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
 Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009



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