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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00895674
First received: May 6, 2009
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895674

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

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov 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
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014