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A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer.

Unique Dataset IDNCT00073307
SponsorBayer HealthCare Pharmaceuticals Inc.Data ProviderBayer HealthCare Pharmaceuticals Inc.Total Study Enrolled Patients769Comparator (Control) Arm Enrolled Patients385RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeBest Supportive Care, Drug, PlaceboDataset TypeADS

Clinical Trial Title

A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer.

Trial Summary and Conditions

This is a randomised, blinded trial to evaluate the clinical benefit of BAY 43-9006 400 mg bid (2x200 mg tablets) when added to Best Supportive Care in patients with unresectable, and/or metastatic RCC (Motzer "intermediate" or "low" risk) who have received one prior systemic anticancer treatment. For this trial, Best Supportive Care is defined as standard elements of care for the patient with advanced cancer; (including analgesics, nutritional support, and other non-anti neoplastic interventions), as per prevailing standards at the clinical center. Concomitant treatment with other cytotoxic or cytostatic agents is prohibited. All patients who meet the entrance criteria will be randomised to receive either BAY 43-9006 400 mg (2x200mg tablets) or matching placebo (orally) administered twice daily in combination with Best Supportive Care. Please see protocol for further details.

Data Summary

The database was the primary data for PFS analysis. It includes all patients randomized (769) as of January 28, 2005, and data accrued up to this date.

Study Objectives

The 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.

Outcome Measures

outcome measures documented in the protocol

Available Downloads:

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

PROTOCOL: 11213 Amd 1 integrated.pdf

CRF: 11213 CRF Blank pages_Updated 2005.pdf

DATA DICTIONARY: documentation of sphads library datasets.rtf


Other: 11213 Annotated CRF.pdf