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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms, Neoplasm Metastasis

Thank you

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 OfficeBridgewater, New Jersey  08807