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Nexavar® as First Targeted Therapy in Patients With Advanced Renal Cell Carcinoma (NEXTAR)

This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01508364
First received: January 3, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.


Condition Intervention
Carcinoma, Renal Cell
 Drug: Sorafenib (Nexavar, BAY 43-9006)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NEXTAR - NEXavar® as First TARgeted Treatment for Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Duration of Nexavar treatment [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 1 - 1.5 years after LPLV ] [ Designated as safety issue: No ]
  • Health related quality of life (HRQoL) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Tumor status, of patients will be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression". [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Incidence of Treatment-emergent Adverse Events (TEAE) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: July 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY 43-9006)
Dosage according to label or at discretion of the attending physician

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of patients with metastatic/advanced RCC (all histologies), who failed prior cytokine therapy or are not suitable for cytokine therapy and for whom Nexavar constitutes first targeted therapy.

Criteria

Inclusion Criteria:

  • Patients with a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar.
  • Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment.

Exclusion Criteria:

  • Prior targeted therapy for RCC
  • Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508364

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Vital GmbH
ClinicalTrials.gov Identifier: NCT01508364     History of Changes
Other Study ID Numbers: 16091, NX1111
Study First Received: January 3, 2012
Last Updated: April 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
renal cell carcinoma, first targeted therapy, observational study

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 May 16, 2013