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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557127
First Posted: March 19, 2012
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of patients in whom the actual dose of sorafenib equaled the planned dose [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Overall tolerability of treatment as measured by rate of adverse events [ Time Frame: 12 months ]

Enrollment: 205
Actual Study Start Date: November 1, 2011
Study Completion Date: March 31, 2016
Primary Completion Date: May 16, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)

  Eligibility

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:   Probability Sample
Study Population
Adult patients with renal cell carcinoma scheduled to treatment with sorafenib, following therapy failure with IFN/IL-2
Criteria

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.
  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): NCT01557127


Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01557127     History of Changes
Other Study ID Numbers: 16268
First Submitted: March 16, 2012
First Posted: March 19, 2012
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bayer:
Renal cell carcinoma,
Sorafenib
Dosing

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