Nexavar Dosing in Renal Cancer Patients in "Real-life" Setting (NEXST)

March 24, 2017 updated by: Bayer

Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Many Locations, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with renal cell carcinoma scheduled to treatment with sorafenib, following therapy failure with IFN/IL-2

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall tolerability of treatment as measured by rate of adverse events
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

May 16, 2014

Study Completion (Actual)

March 31, 2016

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 19, 2012

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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