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Prostate

(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

Unique Data Set IDProstat_Sanofi_2007_83
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients1224Comparator (Control) Arm Enrolled Patients612RandomizationYesClinicalTrial.gov IDNCT00519285ClinicalTrial.gov URLhttp://clinicaltrials.gov/ct2/show/NCT00519285?term=sanofi+venice&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeBiologics, ChemotherapyData Set TypeSDTM

Clinical Trial Title

(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

Trial Summary and Conditions

This dataset was part of the training data curated for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/149

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

The combination regimen of docetaxel / prednisone is the standard of care for the treatment of Metastatic Androgen Independent Prostate Cancer (MAIPC). However, this treatment is not curative, and thus new therapeutic options for patients with this disease are still desperately needed. Induction of new blood vessels is required for expansive prostate tumor growth, and upregulation of VEGF has been shown to be inversely correlated with survival. Therefore, VEGF is a legitimate target, and it is hypothesized that the addition of a VEGF inhibitor to standard treatment will improve overall survival of MAIPC patients. Aflibercept has a high affinity for binding VEGF and other related pro-angiogenic factors. In vivo preclinical models showed an additive activity of aflibercept / taxane combination and dose response activity was observed in human prostate cancer model. Furthermore, convincing clinical evidence in support of VEGF blockade approach demonstrated in randomized studies, may be independent of tumor type.

Therefore, the present randomized placebo-controlled study has been designed to evaluate the efficacy and safety of the addition of aflibercept at the dose of 6mg/kg to the registered doses of docetaxel/prednisone in the first-line treatment of patients with MAIPC. Stratification will be done according to Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0-1 vs 2). Overall survival will be the primary efficacy endpoint, which will be analyzed after approximately 873 patients have died.

Data Summary

These datasets are analysis datasets that bear some resemblance to CDISC ADaM standards. These datasets has been subsetted to include data for only the comparator arm of this clinical trial.

Study Objectives

Primary objective: To demonstrate the efficacy of aflibercept (Arm A) versus placebo (Arm B) in term of overall survival (OS) in patients treated with docetaxel / prednisone or prednisolone for metastatic androgen-independent prostate cancer (MAIPC). Secondary objectives: To assess efficacy of aflibercept compared to placebo for: PSA response Pain response in patients with stable pain at baseline. Time to occurrence of any skeletal related events (SRE). Progression-free survival. Tumor response in patients with measurable disease (RECIST). PSA-Progression free survival (PSA-PFS). Pain-Progression free survival (Pain-PFS). Health-Related Quality of Life (HRQL). To evaluate safety in both treatment arms. To determine the pharmacokinetics of IV aflibercept, in this population. To determine the immunogenicity of IV aflibercept.

Outcome Measures

N/A

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Sanofi Study Protocol Venice.pdf

CRF: Sanofi CRF Venice.pdf

DATA (COMPARATOR ARM): Sanofi Data Venice.zip

DATA (COMPARATOR ARM): Sanofi Data Descriptors Venice.zip