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Maintenance Rituximab for Follicular Lymphoma

Azacitidine Improves Survival in MDS

Second Stem Cell Transplant Not Helpful in Myeloma
Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overPharmaceutical / IndustryEFC6546
EUDRACT : 2006-004756-20, NCT00519285

Trial Description

Summary

The primary objective of the study is to demonstrate an improvement of overall survival in patients treated with aflibercept versus placebo, in patients receiving docetaxel/ prednisone. Main secondary endpoints gather prostate-specific antigen (PSA) response, pain response,time to occurrence of skeletal related events and progression free survival (PFS), as well as safety, pharmacokinetics and immunogenicity.

Eligibility Criteria

Inclusion Criteria:

  • Histologically- or cytologically-confirmed prostate adenocarcinoma
  • Metastatic disease
  • Progressive disease while receiving hormonal therapy or after surgical castration
  • Effective castration

Exclusion Criteria:

  • Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed > 3 years ago
  • Prior treatment with VEGF inhibitors or VEGF receptor inhibitors
  • Eastern Cooperative Oncology Group performance status > 2

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis - US - Bridgewater

Regeneron Pharmaceuticals

ICDStudy Director

Public registry ICD
  Email: GV-Contact-us@sanofi-aventis.com

Trial Sites

U.S.A.
New Jersey
  Bridgewater
 Sanofi-Aventis - US - Bridgewater
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Argentina
  Buenos Aires
 Sanofi-Aventis Argentina
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Australia
New South Wales
  Cove
 Sanofi-Aventis Australia
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Belgium
  Diegem
 Sanofi-Aventis Belgium
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Brazil
  Sao Paulo
 Sanofi-Aventis Brazil
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Canada
Quebec
  Laval
 Sanofi-Aventis Canada
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Chile
  Santiago
 Sanofi-Aventis Chile
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Czech Republic
  Praha
 Sanofi-Aventis Czech Republic
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Denmark
  Horsholm
 Sanofi-Aventis Denmark
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Estonia
  Tallinn
 Sanofi-Aventis Estonia
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
France
  Paris
 Sanofi-Aventis France
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Germany
  Berlin
 Sanofi-Aventis Germany
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Hong Kong
  Causeway Bay
 Sanofi-Aventis Hong Kong
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Hungary
  Budapest
 Sanofi-Aventis Hungary
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Italy
  Milan
 Sanofi-Aventis Italy
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Netherlands
  Gouda
 Sanofi-Aventis Netherlands
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Poland
  Warszawa
 Sanofi-Aventis Poland
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Portugal
  Porto Salvo
 Sanofi-Aventis Portugal
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Republic of Korea
  Seoul
 Sanofi-Aventis South Korea
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Republic of Singapore
  Singapore
 Sanofi-Aventis Singapore Private Limited
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Republic of South Africa
  Midrand
 Sanofi-Aventis South Africa
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Russia
  Moscow
 Sanofi-Aventis Russia
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Spain
  Barcelona
 Sanofi-Aventis Spain - Barcelona
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Sweden
  Bromma
 Sanofi-Aventis Sweden
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Switzerland
  Geneva
 Sanofi-Aventis Switzerland
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Taiwan, Province of China
  Taipei
 Sanofi-Aventis Taiwan
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
Turkey
  Istanbul
 Sanofi-Aventis Turkey
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com
United Kingdom
  Guildford
 Sanofi-Aventis United Kingdom
 Contact Person
  Email: GV-Contact-us@sanofi-aventis.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00519285
Information obtained from ClinicalTrials.gov on May 13, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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