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

Tracking Information

First Received Date ^ICMJE

January 3, 2012

Last Updated Date

April 25, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Duration of Nexavar® treatment [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01508364 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Carcinoma, Renal Cell

Intervention ^ICMJE

Drug: Sorafenib (Nexavar, BAY 43-9006)

Dosage according to label or at discretion of the attending physician

Study Group/Cohort (s)

Group 1

Intervention: Drug: Sorafenib (Nexavar, BAY 43-9006)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

March 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01508364

Other Study ID Numbers ^ICMJE

16091, NX1111

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Vital GmbH

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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