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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: June 21, 2016
Last verified: June 2016
Results First Received: April 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Prostatic Neoplasms
Neoplasm Metastasis
Interventions: Drug: Aflibercept
Drug: Placebo (for aflibercept)
Drug: Docetaxel
Drug: Prednisone or Prednisolone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between August 2007 and February 2010, a total of 1548 patients gave informed consent for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Amongst these patients, a total of 324 were screening failures (primarily due to non-compliance with exclusion criteria) and did not get randomized.

Reporting Groups
  Description
Placebo Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
Aflibercept Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily

Participant Flow:   Overall Study
    Placebo   Aflibercept
STARTED   612 [1]   612 [1] 
TREATED   604 [2]   605 [3] 
Still Treated at Cut-off Date   1 [4]   2 
COMPLETED   0 [5]   0 
NOT COMPLETED   612   612 
Adverse Event                127                266 
Disease progression                334                186 
Physician Decision                75                47 
Participant's request                53                84 
Consent withdrawn                4                5 
Poor compliance to protocol                5                7 
Reason unspecified                5                8 
Not treated                8                7 
Treatment ongoing                1                2 
[1] Randomized
[2] Received at least part of one dose of placebo
[3] Received at least part of one dose of aflibercept
[4] The cut-off date for analysis was defined as 07 February 2012, date at which 873 deaths has occurred
[5] Participants were treated until progressive disease, unacceptable toxicity, or refusal of treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
Aflibercept Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
Total Total of all reporting groups

Baseline Measures
   Placebo   Aflibercept   Total 
Overall Participants Analyzed 
[Units: Participants]
 612   612   1224 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.6  (8.0)   67.9  (7.8)   67.8  (7.9) 
Age, Customized 
[Units: Participants]
     
<65 years   225   195   420 
65-74 years   259   283   542 
≥75 years   128   134   262 
Gender, Customized 
[Units: Participants]
     
Male   612   612   1224 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian/White   552   560   1112 
Black   17   15   32 
Asian/Oriental   36   32   68 
Other   7   5   12 
Region of Enrollment 
[Units: Participants]
     
Western Europe   219   227   446 
Eastern Europe   131   132   263 
North America   81   95   176 
South America   88   71   159 
Other region   93   87   180 
Body Surface Area (BSA) 
[Units: M²]
Mean (Standard Deviation)
 2.0  (0.2)   2.0  (0.2)   2.0  (0.2) 
Eastern Co-operative Group (ECOG) performance status [1] 
[Units: Participants]
     
ECOG 0   285   283   568 
ECOG 1   299   303   602 
ECOG 2   28   26   54 
[1]

ECOG performance status:

  • 0 = Fully active, able to carry on all pre-disease performance without restriction
  • 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  • 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours


  Outcome Measures
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1.  Primary:   Overall Survival Time   [ Time Frame: From randomization up to the cut-off date (median follow-up of 35.4 months) ]

2.  Secondary:   Prostate Specific Antigen Response Rate   [ Time Frame: Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first ]

3.  Secondary:   Time to Skeletal Related Events   [ Time Frame: From randomization up to the cut-off date (median follow-up of 35.4 months) ]

4.  Secondary:   Progression Free Survival Time   [ Time Frame: From randomization up to the cut-off date (median follow-up of 35.4 months) ]

5.  Secondary:   Tumor Response Rate in Participants With Measurable Disease   [ Time Frame: Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first ]

6.  Secondary:   Prostate Specific Antigen Progression-free Survival Time   [ Time Frame: From randomization up to the cut-off date (median follow-up of 35.4 months) ]

7.  Secondary:   Pain Progression-free Survival Time   [ Time Frame: From randomization up to the cut-off date (median follow-up of 35.4 months) ]

8.  Secondary:   Pain Response Rate   [ Time Frame: Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first ]

9.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life   [ Time Frame: Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first ]

10.  Secondary:   Number of Participants With Adverse Events as a Measure of Safety   [ Time Frame: From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days ]

11.  Secondary:   Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept   [ Time Frame: Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Pain response initially defined as a key secondary endpoint together with PSA response, time to occurence of SRE and PFS was finally considered as an exploratory endpoint in final statistical analysis plan.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-Us@sanofi.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00519285     History of Changes
Other Study ID Numbers: EFC6546
2006-004756-20 ( EudraCT Number )
Study First Received: August 21, 2007
Results First Received: April 25, 2013
Last Updated: June 21, 2016
Health Authority: United States: Food and Drug Administration