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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 CancerUnique Dataset IDProstat_Sanofi_2007_79
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.
These are SDTM datasets subsetted to include data only the comparator arm data of this clinical trial.
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
Outcomes documented in the protocol
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