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

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ClinicalTrials.gov Identifier: NCT00895674
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : September 30, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Carcinoma, Renal Cell Carcinoma, Renal Cell (Advanced) Drug: Nexavar (Sorafenib, BAY43-9006)

Study Design

Study Type : Observational
Actual Enrollment : 2840 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar
Study Start Date : July 2006
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Tumor status [ Time Frame: After about 3, 6, 9 and 12 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895674


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

Additional Information:
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
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: September 30, 2010
Last Verified: September 2010

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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action