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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01508364
First received: January 3, 2012
Last updated: March 28, 2014
Last verified: March 2014

January 3, 2012
March 28, 2014
July 2012
December 2013   (final data collection date for primary outcome measure)
Duration of Nexavar treatment [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Duration of Nexavar® treatment [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01508364 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Nexavar as First Targeted Therapy in Patients With Advanced Renal Cell Carcinoma
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY 43-9006)
Dosage according to label or at discretion of the attending physician
Group 1
Intervention: Drug: Sorafenib (Nexavar, BAY 43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2014
December 2013   (final data collection date for primary outcome measure)

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).
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01508364
16091, NX1111
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2014

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