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Nexavar Dosing in Renal Cancer Patients in Real-life Setting

Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01557127
Acronym
NEXST
Enrollment
205
Registered
2012-03-19
Start date
2011-11-01
Completion date
2016-03-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell

Keywords

Renal cell carcinoma,, Sorafenib, Dosing

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.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose12 months

Secondary

MeasureTime frame
Overall tolerability of treatment as measured by rate of adverse events12 months

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026