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

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. Identifier: NCT01557127
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : March 28, 2017
Information provided by (Responsible Party):

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

Study Type : Observational
Actual Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma
Actual Study Start Date : November 1, 2011
Actual Primary Completion Date : May 16, 2014
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)

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

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

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

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.

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 identifier (NCT number): NCT01557127

Many Locations, Poland
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01557127     History of Changes
Other Study ID Numbers: 16268
First Posted: March 19, 2012    Key Record Dates
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,

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