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Type(s) of Cancer
Kidney
Study Phase
Phase 3
Study Completion Date
September 2006
NCT00073307Uploaded 03-27-2014
Available for Download
PDS UID: Kidney_BayerAG_2003_97
A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
Provider Information
Provider Data DescriptionThe primary efficacy objective of the study was to compare the overall survival between patients treated with Bay 43-9006 versus placebo. Secondary objectives include PFS, best overall response rate, and HRQOL. Primary alpha for the study was allocated between overall survival and PFS.
SponsorBayer HealthCare Pharmaceuticals Inc.
Data ProviderBayer HealthCare Pharmaceuticals Inc.
Partial set or SubsetOriginal Data
Patients in dataset769
# of Patients Control385
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/wsv3-3306
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
ConditionsCarcinoma, Renal Cell
Intervention TypeDrug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo
Drug(s)Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo
Total Enrolled903
RandomizationRandomized
Blinding MethodTriple
Arms InterventionSorafenib (Nexavar, BAY43-9006) - Experimental
Placebo - Placebo Comparator
Secondary IDN/A
PubMed (PMID)20085939
20399677
19850637
19757215
20651059
19451442
18840822
17551296
17215530
17189398
16965911
35484400
34775477
Collaborator(s)Amgen
Region(s)United States
Argentina
Australia
Belgium
Brazil
Canada
Chile
France
Germany
Hungary
Israel
Italy
Netherlands
Poland
Russian Federation
South Africa
Spain
Ukraine
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOL11213 Amd 1 integrated.pdf
CRF11213 CRF Blank pages_Updated 2005.pdf
DATA DICTIONARYdocumentation of sphads library datasets.rtf
DATA (COMPARATOR ARM)11213ads.zip
Other11213 Annotated CRF.pdf
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