Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

September 29, 2010 updated by: Bayer
Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2840

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

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

Non-Probability Sample

Study Population

Patients with a diagnosis of advanced RCC

Description

Inclusion Criteria:

  • Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Nexavar (Sorafenib, BAY43-9006)
Patients with a diagnosis of advanced RCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor status
Time Frame: After about 3, 6, 9 and 12 months
After about 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment duration
Time Frame: At end of study after about 12 months
At end of study after about 12 months
Safety of sorafenib treatment
Time Frame: At every documented visit for about 12 months
At every documented visit for about 12 months
Progression-free survival
Time Frame: Calculation at end of study after about 12 months
Calculation at end of study after about 12 months
Status of Metastases
Time Frame: After about 3, 6, 9 and 12 months
After about 3, 6, 9 and 12 months
Performance status (ECOG)
Time Frame: After about 3, 6, 9 and 12 months
After about 3, 6, 9 and 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

July 1, 2006

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (Estimate)

May 8, 2009

Study Record Updates

Last Update Posted (Estimate)

September 30, 2010

Last Update Submitted That Met QC Criteria

September 29, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14686
  • PREDICT (CardioDx)
  • 12943
  • 12731
  • 13211
  • 13068
  • 13277 (Other Identifier: City of Hope Medical Center)
  • 13049
  • 14242
  • 14178
  • NX0601
  • 12649
  • 12650
  • 12808
  • 12807
  • 12806
  • 12755
  • 12730
  • 12944
  • 13094
  • 13167
  • 13209
  • 13210
  • 13274
  • 13601
  • 13121
  • 13095

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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