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Pancreatic

A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen

Unique Data Set IDPancrea_Sanofi_2006_109
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients453Comparator (Control) Arm Enrolled Patients231RandomizationYesClinicalTrial.gov IDNCT00417208ClinicalTrial.gov URLhttp://clinicaltrials.gov/ct2/show/NCT00417209?term=EFC6596&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen

Trial Summary and Conditions

Previous results suggest that larotaxel may provide an additional therapeutic option for patients with pancreatic carcinoma maintaining a good performance status while progressing under gemcitabine-containing chemotherapy. It is therefore proposed to investigate larotaxel in pancreas cancer failing after a gemcitabine-based therapy as a treatment option for APC.

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 end-point: - Overall survival will be assessed from the date of randomization to death. Main Secondary End-points: - Progression free survival will be evaluated from date of randomization to tumor progression or death. - Objective responses (CR and PR) as assessed by investigators according to RECIST criteria - Safety profile of the study treatment in terms of AEs/ SAEs and laboratory parameters. - Clinical Benefit will be based on the measurement of tumor related symptoms including a composite score of pain severity assessed by Visual Analog Scale (VAS), analgesic consumption as morphine equivalents, ECOG PS and weight loss of greater than or equal to 5% from baseline. The Clinical Benefit will be assessed by time to symptom worsening (TTSW).

Outcome Measures

Outcomes documented in the protocol

Available Downloads:

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

PROTOCOL: sanofi_XRP9881_efc6596_protocol_Redacted.pdf

CRF: sanofi_XRP9881_EFC6596_Sample_CRF_redacted.pdf

DATA DICTIONARY: Read me first-info data definition files XRP9881 EFC6596.docx

DATA (COMPARATOR ARM): SAS datasets.zip

Other: data definition files.zip