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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: March 16, 2012
Last updated: March 24, 2017
Last verified: March 2017
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)


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.
  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: NCT01557127

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

Additional Information:
Responsible Party: Bayer Identifier: NCT01557127     History of Changes
Other Study ID Numbers: 16268
Study First Received: March 16, 2012
Last Updated: March 24, 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 processed this record on September 21, 2017