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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: May 6, 2009
Last updated: September 29, 2010
Last verified: September 2010
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.

Condition Intervention
Carcinoma, Renal Cell
Carcinoma, Renal Cell (Advanced)
Drug: Nexavar (Sorafenib, BAY43-9006)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Tumor status [ Time Frame: After about 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment duration [ Time Frame: At end of study after about 12 months ] [ Designated as safety issue: No ]
  • Safety of sorafenib treatment [ Time Frame: At every documented visit for about 12 months ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Calculation at end of study after about 12 months ] [ Designated as safety issue: No ]
  • Status of Metastases [ Time Frame: After about 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Performance status (ECOG) [ Time Frame: After about 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 2840
Study Start Date: July 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Nexavar (Sorafenib, BAY43-9006)
Patients with a diagnosis of advanced RCC


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of advanced RCC

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00895674

  Show 18 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00895674     History of Changes
Other Study ID Numbers: 14686  NX0601  PREDICT  12649  12650  12943  12808  12807  12806  12755  12731  12730  12944  13094  13167  13209  13210  13211  13274  13277  13601  14178  14242  13068  13121  13095  13049 
Study First Received: May 6, 2009
Last Updated: September 29, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Ethikkommission
China: Ethics Committee
Colombia: Ethics Committee
Czech Republic: State Institute for Drug Control
France: French Data Protection Authority
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
Indonesia: National Agency of Drug and Food Control
South Korea: Korea Food and Drug Administration (KFDA)
Mexico: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Philippines: Bureau of Food and Drugs
Philippines: Department of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ethics Committee
Slovakia: State Institute for Drug Control
Slovenia: Ethics Committee
Sweden: Regional Ethical Review Board

Keywords provided by Bayer:
Advanced Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 26, 2016