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Prostate

A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer

Unique Data Set IDProstat_Sanofi_2007_79
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients755Comparator (Control) Arm Enrolled Patients371RandomizationYesClinicalTrial.gov IDNCT00417079ClinicalTrial.gov URLhttp://www.clinicaltrials.gov/ct2/show/NCT00417079?term=EFC6193&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeSDTM

Clinical Trial Title

A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer

Trial Summary and Conditions

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

Based on a very good pre-clinical activity, a favorable safety profile in addition to the early activity observed in prostate cancer and taxane resistant Metastatic Breast Cancer (MBC) patients, it was hypothesized that cabazitaxel in combination with prednisone may prolong survival in prostate cancer patients that failed a docetaxel containing regimen.

Data Summary

These are SDTM datasets subsetted to include data only the comparator arm data of this clinical trial.

Study Objectives

Primary: • To determine whether XRP6258 in combination with prednisone improves overall survival (OS) when compared to mitoxantrone in combination with prednisone Secondary: • To compare efficacy between the two treatment arms: - PSA Response - PSA Progression - Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), PSA progression, pain progression or death due to any cause. - Overall Response Rate (ORR) - Pain Response - Pain Progression • To assess the overall safety of XRP6258 in combination with prednisone • To assess the pharmacokinetics of XRP6258 and its metabolite, RPR123142, in this patient population and effect of prednisone on the pharmacokinetics of XRP6258

Outcome Measures

Outcomes documented in the protocol

Available Downloads:

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

PROTOCOL: Sanofi Study Protocol Tropic.pdf

CRF: Sanofi CRF Tropic.pdf

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

DATA (COMPARATOR ARM): Sanofi Data Tropic.zip