Trial Information
A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
Study period
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
EFC6546
NCT ID:
NCT00519285
Start Date:
August 2007
Completion Date:
April 2012
Related Keywords:
- Prostatic Neoplasms
- Neoplasm Metastasis
- metastatic
- prostate
- cancer
- Neoplasms
- Neoplasm Metastasis
- Prostatic Neoplasms
Name | Location |
Sanofi-Aventis Administrative Office |
Bridgewater, New Jersey 08807 |