NCT00519285|CompletedPhase 3ResultsDMC

Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

VENICE

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

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC65462006-004756-20

Study Type

interventional

Target

1,224

Locations

30 countries

Sites

Timeline

RegisteredAug 2007

StartedAug 2007

CompletionApr 2012

Brief Summary

Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC). The secondary objectives were:

To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);
To assess the overall safety in both treatment arms;
To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;
to determine immunogenicity of IV aflibercept.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,224

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Aug 2007

Longer than P75 for phase_3

Geographic Reach

30 countries

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.7 years study duration

Study Start

First participant enrolled

August 1, 2007

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

October 10, 2013

Completed

Last Updated

July 22, 2016

Status Verified

June 1, 2016

Enrollment Period

4.7 years

First QC Date

August 21, 2007

Results QC Date

April 25, 2013

Last Update Submit

June 21, 2016

Conditions

Prostatic Neoplasms Neoplasm Metastasis

Keywords

metastaticprostatecancer

Outcome Measures

Primary Outcomes (1)

Overall Survival Time
Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause. The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier.
From randomization up to the cut-off date (median follow-up of 35.4 months)

Secondary Outcomes (10)

Prostate Specific Antigen Response Rate
Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first
Time to Skeletal Related Events
From randomization up to the cut-off date (median follow-up of 35.4 months)
Progression Free Survival Time
From randomization up to the cut-off date (median follow-up of 35.4 months)
Tumor Response Rate in Participants With Measurable Disease
Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first
Prostate Specific Antigen Progression-free Survival Time
From randomization up to the cut-off date (median follow-up of 35.4 months)
+5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone

Drug: Placebo (for aflibercept)Drug: DocetaxelDrug: Prednisone or Prednisolone

Aflibercept

EXPERIMENTAL

Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone

Drug: AfliberceptDrug: DocetaxelDrug: Prednisone or Prednisolone

Interventions

AfliberceptDRUG

25 mg/ml solution 6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle

Also known as: AVE0005, ZALTRAP®)

Aflibercept

Placebo (for aflibercept)DRUG

Sterile aqueous buffered solution identical to aflibercept 1-hour IV on Day 1 of each 3-Week cycle

Placebo

DocetaxelDRUG

Marketed formulation 75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)

Also known as: Taxotere®

AfliberceptPlacebo

Prednisone or PrednisoloneDRUG

Marketed formulation 5 mg twice daily PO from day 1 continuously

AfliberceptPlacebo

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically- or cytologically-confirmed prostate adenocarcinoma;
Metastatic disease;
Progressive disease while receiving hormonal therapy or after surgical castration;
Effective castration.

You may not qualify if:

Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed \>3 years ago;
Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF receptor inhibitors;
Eastern Cooperative Oncology Group (ECOG) performance status \>2.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.