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NCT01557127 Clinical Trial

Nexavar Dosing in Renal Cancer Patients in "Real-life" Setting

Carcinoma, Renal Cell Clinical Trial

— NEXST  

Official title:
Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01557127
Other study ID # 16268
Secondary ID
Status Completed
Phase N/A
First received March 16, 2012
Last updated March 24, 2017
Start date November 1, 2011
Est. completion date March 31, 2016

Study information
Verified date March 2017
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 205
Est. completion date March 31, 2016
Est. primary completion date May 16, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients in whom the actual dose of sorafenib equaled the planned dose 12 months
Secondary Overall tolerability of treatment as measured by rate of adverse events 12 months
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