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Clinical Trials/NCT01557127
NCT01557127
Completed
Not Applicable

Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma

Bayer0 sites205 target enrollmentNovember 1, 2011
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ConditionsCarcinoma, Renal Cell
InterventionsSorafenib (Nexavar, BAY43-9006)
DrugsSorafenib (Nexavar, BAY43-9006)

Overview

Phase
Not Applicable
Intervention
Sorafenib (Nexavar, BAY43-9006)
Conditions
Carcinoma, Renal Cell
Sponsor
Bayer
Enrollment
205
Primary Endpoint
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.

Registry
clinicaltrials.gov
Start Date
November 1, 2011
End Date
March 31, 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Age \>/= 18 years
  • •Diagnosis of renal cell carcinoma
  • •Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2
  • •Patients in whom the oncologist has decide to start therapy with sorafenib.

Exclusion Criteria

  • •Synonymous with contraindications to Nexavar.

Arms & Interventions

Group 1

Intervention: Sorafenib (Nexavar, BAY43-9006)

Outcomes

Primary Outcomes

Percentage of patients in whom the actual dose of sorafenib equaled the planned dose

Time Frame: 12 months

Secondary Outcomes

  • Overall tolerability of treatment as measured by rate of adverse events(12 months)

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