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

January 19, 2015 updated by: Bayer

NEXTAR - NEXavar® as First TARgeted Treatment for Patients With Advanced Renal Cell Carcinoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Sorafenib (Nexavar, BAY 43-9006)
Dosage according to label or at discretion of the attending physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of Nexavar treatment
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: up to 3 years
up to 3 years
Overall Survival (OS)
Time Frame: 1 - 1.5 years after LPLV
1 - 1.5 years after LPLV
Health related quality of life (HRQoL)
Time Frame: up to 3 years
up to 3 years
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
up to 3 years
Incidence of Treatment-emergent Adverse Events (TEAE)
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16091
  • NX1111 (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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