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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
September 2009
NCT00417079Uploaded 09-04-2013
Available for Download
PDS UID: Prostat_Sanofi_2007_79
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 Previously Treated With A Taxotere®-Containing Regimen
Provider Information
Provider Data DescriptionPrimary: - 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
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset755
# of Patients Control371
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/m3ye-cq41
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
ConditionsNeoplasms
Prostatic Neoplasms
Intervention TypeDrug: cabazitaxel (XRP6258) (RPR116258)
Drug: mitoxantrone
Drug: prednisone
Drug(s)Drug: mitoxantrone
Drug: prednisone
Drug: cabazitaxel (XRP6258) (RPR116258)
Total Enrolled755
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionMitoxantrone + Prednisone - Active Comparator
Cabazitaxel + Prednisone - Experimental
Secondary IDN/A
PubMed (PMID)25538172
23723295
22743148
20888992
Collaborator(s)N/A
Region(s)United States
Argentina
Belgium
Brazil
Canada
Chile
Czech Republic
Denmark
Finland
France
Germany
Hungary
India
Italy
Korea, Republic of
Mexico
Netherlands
Russian Federation
Singapore
Slovakia
South Africa
Spain
Sweden
Taiwan
Turkey
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLSanofi Study Protocol Tropic.pdf
CRFSanofi CRF Tropic.pdf
DATA (COMPARATOR ARM)Sanofi Data Descriptors Tropic.zip
DATA (COMPARATOR ARM)Sanofi Data Tropic.zip
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