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Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer (VENICE)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00519285
First received: August 21, 2007
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Neoplasm Metastasis
 Drug: Aflibercept (AVE0005)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA measurement [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Pain measurement [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Occurrence of skeletal related events [ Time Frame: Study period ] [ Designated as safety issue: No ]

Enrollment: 1224
Study Start Date: August 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: Aflibercept (AVE0005)
Associated to docetaxel and prednisone or prednisolone
Placebo Comparator: Arm B Drug: Placebo
Associated to docetaxel and prednisone or prednisolone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519285

  Show 31 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00519285     History of Changes
Other Study ID Numbers: EFC6546, EUDRACT : 2006-004756-20
Study First Received: August 21, 2007
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
metastatic
prostate
cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
 Prednisone
Docetaxel
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013