Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer (VENICE)
This study has been completed.
Sponsor:
Sanofi
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
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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:
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
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Hide Study LocationsLocations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Argentina | |
| Sanofi-Aventis Administrative Office | |
| Buenos Aires, Argentina | |
| Australia | |
| Sanofi-Aventis Administrative Office | |
| Macquarie Park, Australia | |
| Belgium | |
| Sanofi-Aventis Administrative Office | |
| Diegem, Belgium | |
| Brazil | |
| Sanofi-Aventis Administrative Office | |
| Sao Paulo, Brazil | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| Chile | |
| Sanofi-Aventis Administrative Office | |
| Providencia Santiago, Chile | |
| Croatia | |
| Sanofi-Aventis Administrative Office | |
| City of Zagreb, Croatia | |
| Czech Republic | |
| Sanofi-Aventis Administrative Office | |
| Praha, Czech Republic | |
| Denmark | |
| Sanofi-Aventis Administrative Office | |
| Horsholm, Denmark | |
| Estonia | |
| Sanofi-Aventis Administrative Office | |
| Tallinn, Estonia | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Germany | |
| Sanofi-Aventis Administrative Office | |
| Frankfurt, Germany | |
| Hong Kong | |
| Sanofi-Aventis Administrative Office | |
| Hong Kong, Hong Kong | |
| Hungary | |
| Sanofi-Aventis Administrative Office | |
| Budapest, Hungary | |
| Israel | |
| Sanofi-Aventis Administrative Office | |
| Natanya, Israel | |
| Italy | |
| Sanofi-Aventis Administrative Office | |
| Milan, Italy | |
| Korea, Republic of | |
| Sanofi-Aventis Administrative Office | |
| Seoul, Korea, Republic of | |
| Netherlands | |
| Sanofi-Aventis Administrative Office | |
| Gouda, Netherlands | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warsaw, Poland | |
| Portugal | |
| Sanofi-Aventis Administrative Office | |
| Porto Salvo, Portugal | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
| Singapore | |
| Sanofi-Aventis Administrative Office | |
| Singapore, Singapore | |
| South Africa | |
| Sanofi-Aventis Administrative Office | |
| Gauteng, South Africa | |
| Spain | |
| Sanofi-Aventis Administrative Office | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-Aventis Administrative Office | |
| Bromma, Sweden | |
| Switzerland | |
| Sanofi-Aventis Administrative Office | |
| Geneva, Switzerland | |
| Taiwan | |
| Sanofi-Aventis Administrative Office | |
| Taipei, Taiwan | |
| Turkey | |
| Sanofi-Aventis Administrative Office | |
| Istanbul, Turkey | |
| Ukraine | |
| Sanofi-Aventis Administrative Office | |
| Kiev, Ukraine | |
| United Kingdom | |
| Sanofi-Aventis Administrative Office | |
| Guildford Surrey, United Kingdom | |
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 May 19, 2013