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

Carcinoma, Renal Cell Clinical Trial

— NEXTAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508364
• Other study ID #: 16091
• Secondary ID: NX1111
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: January 19, 2015
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• Sorafenib (Nexavar, BAY 43-9006)
Dosage according to label or at discretion of the attending physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Nexavar treatment		up to 3 years	No
Secondary	Overall Survival (OS)		1 - 1.5 years after LPLV	No
Secondary	Health related quality of life (HRQoL)		up to 3 years	No
Secondary	Progression-free survival (PFS)		up to 3 years	No
Secondary	Tumor status, of patients will be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression".		up to 3 years	No
Secondary	Incidence of Treatment-emergent Adverse Events (TEAE)		up to 3 years	Yes

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