`
`Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer (VENICE)
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`Latest version (submitted June 21, 2016) on ClinicalTrials.gov
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`A study version is represented by a row in the table.
`
`Select two study versions to compare. One each from columns A and B.
`
`Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
`
`Click "Compare" to do the comparison and show the differences.
`
`Select a version's Submitted Date link to see a rendering of the study for that version.
`
`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
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`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
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`Study edits or deletions are displayed in red .
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`Study additions are displayed in green .
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`Study Record Versions
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`Version
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`A
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`B
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`Submitted Date
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`Changes
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`1
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`2
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`3
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`August 21, 2007 None (earliest Version on record)
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`December 31, 2007 Contacts/Locations, Study Status and Sponsor/Collaborators
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`April 25, 2008 Study Status and Contacts/Locations
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`Exhibit 2078
`Page 01 of 13
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`Version
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`A
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`B
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`Submitted Date
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`Changes
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`4
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`5
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`6
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`7
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`8
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`9
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`10
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`11
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`12
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`13
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`14
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`15
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`16
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`June 2, 2008 Study Status
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`August 21, 2008 Arms and Interventions, Outcome Measures, Study Design and Study Status
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`January 12, 2009 Study Status and Study Identification
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`July 3, 2009 Contacts/Locations, Study Status and References
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`August 13, 2009 Contacts/Locations, Study Status and Study Identification
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`January 29, 2010 Contacts/Locations and Study Status
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`February 2, 2010 Study Status and Contacts/Locations
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`February 12, 2010 Recruitment Status, Study Status and Contacts/Locations
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`August 30, 2011 Sponsor/Collaborators, Study Status and Contacts/Locations
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`April 16, 2012 Recruitment Status, Study Status, Outcome Measures, Study Design and Study Description
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`April 20, 2012 Study Status
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`August 2, 2013 Outcome Measures, Arms and Interventions, Study Status, Study Identification, Study Description, Results,
`References, Eligibility and Oversight
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`June 21, 2016 Study Status and Baseline Characteristics
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`Compare
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` Comparison Format:
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` Merged
` Side-by-Side
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`Scroll up to access the controls
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`Study NCT00519285
`Submitted Date: August 21, 2007 (v1)
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`Exhibit 2078
`Page 02 of 13
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` Study Identification
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`Unique Protocol ID: EFC6546
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`Brief Title: Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
`(VENICE)
`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
`
`Secondary IDs: AVE0005
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` Study Status
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`Record Verification: August 2007
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`Overall Status: Recruiting
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`Study Start: August 2007
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`Primary Completion:
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`Study Completion:
`
`First Submitted: August 21, 2007
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`August 21, 2007
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`First Submitted that
`Met QC Criteria:
`First Posted: August 22, 2007 [Estimate]
`
`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: August 22, 2007 [Estimate]
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`August 21, 2007
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`Exhibit 2078
`Page 03 of 13
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` Sponsor/Collaborators
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`Sponsor: Sanofi
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`Responsible Party:
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`Collaborators: Regeneron Pharmaceuticals
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` Oversight
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`U.S. FDA-regulated Drug:
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`U.S. FDA-regulated Device:
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`Data Monitoring:
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` Study Description
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`Brief 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.
`
`Detailed Description:
`
`Exhibit 2078
`Page 04 of 13
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` Conditions
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`Conditions: Prostatic Neoplasms
`Neoplasm Metastasis
`Keywords: metastatic
`prostate
`cancer
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` Study Design
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`Study Type: Interventional
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`Primary Purpose: Treatment
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`Study Phase: Phase 3
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`Interventional Study Model: Parallel Assignment
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`Number of Arms:
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`Masking: Double (masked roles unspecified)
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`Allocation: Randomized
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`Enrollment: 1200 [Anticipated]
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` Arms and Interventions
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`Intervention Details:
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`Drug: aflibercept (VEGF Trap)
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`Exhibit 2078
`Page 05 of 13
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` Outcome Measures
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`Primary Outcome Measures:
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`Secondary Outcome Measures:
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`1. Overall survival
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`1. PSA measurement, pain measurement, occurrence of skeletal related events
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`Exhibit 2078
`Page 06 of 13
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` Eligibility
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`Minimum Age: 18 Years
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`Maximum Age:
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`Sex: Male
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`Gender Based:
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`Accepts Healthy Volunteers: No
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`Criteria: Inclusion Criteria:
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`Histologically- or cytologically-confirmed prostate adenocarcinoma
`Metastatic disease
`Progressive disease while receiving hormonal therapy or after surgical castration
`Effective castration
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`Exclusion Criteria:
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`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.
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` Contacts/Locations
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`Central Contact Person: Public registry ICD
`Email: GV-Contact-us@sanofi-aventis.com
`Locations: United States, New Jersey
`
`Exhibit 2078
`Page 07 of 13
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`
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`Sanofi-Aventis Administrative Office
`[Recruiting]
`Bridgewater, New Jersey, United States, 08807
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Argentina
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Buenos Aires, Argentina
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Australia, New South Wales
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Cove, New South Wales, Australia
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Belgium
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Diegem, Belgium
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Brazil
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Sao Paulo, Brazil
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Canada, Quebec
`
`Exhibit 2078
`Page 08 of 13
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`
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`Sanofi-Aventis Administrative Office
`[Recruiting]
`Laval, Quebec, Canada
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Chile
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Santiago, Chile
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Czech Republic
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Praha, Czech Republic
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Denmark
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Horsholm, Denmark
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Estonia
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Tallinn, Estonia
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`France
`
`Exhibit 2078
`Page 09 of 13
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`
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`Contact: +33(0)800 222 555
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`Sanofi-Aventis Administrative Office
`[Recruiting]
`Paris, France
`Contact:
`Germany
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Berlin, Germany
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Hong Kong
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Causeway Bay, Hong Kong
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Hungary
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Budapest, Hungary
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Italy
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Milan, Italy
`Contact: GV-Contact-us@sanofi-aventis.com
`Contact:
`Korea, Republic of
`
`Exhibit 2078
`Page 10 of 13
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`
`
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Seoul, Korea, Republic of
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Netherlands
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Gouda, Netherlands
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Poland
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Warszawa, Poland
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Portugal
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Porto Salvo, Portugal
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Russian Federation
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Moscow, Russian Federation
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Singapore
`
`Exhibit 2078
`Page 11 of 13
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`
`
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Singapore, Singapore
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`South Africa
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Midrand, South Africa
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Spain
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Barcelona, Spain
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Sweden
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Bromma, Sweden
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Switzerland
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Geneva, Switzerland
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`Taiwan
`
`Exhibit 2078
`Page 12 of 13
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`
`
`Contact: GV-Contact-us@sanofi-aventis.com
`
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Taipei, Taiwan
`Contact:
`Turkey
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Istanbul, Turkey
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`United Kingdom, Surrey
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Guildford, Surrey, United Kingdom
`Contact:
`Contact: GV-Contact-us@sanofi-aventis.com
`
` IPDSharing
`
`Plan to Share IPD:
`
` References
`
`Links: URL: http://www.sanofi-aventis.com
`Description: Related Info
`
`
`
`Available IPD/Information:
`
`Scroll up to access the controls
`
`Scroll to the Study top
`
`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
`
`Exhibit 2078
`Page 13 of 13
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