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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01508364
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):

January 3, 2012
January 12, 2012
January 21, 2015
July 2012
December 2013   (Final data collection date for primary outcome measure)
Duration of Nexavar treatment [ Time Frame: up to 3 years ]
Same as current
Complete list of historical versions of study NCT01508364 on Archive Site
  • Overall Survival (OS) [ Time Frame: 1 - 1.5 years after LPLV ]
  • Health related quality of life (HRQoL) [ Time Frame: up to 3 years ]
  • Progression-free survival (PFS) [ Time Frame: 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 ]
  • Incidence of Treatment-emergent Adverse Events (TEAE) [ Time Frame: up to 3 years ]
Same as current
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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.
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Observational Model: Cohort
Time Perspective: Prospective
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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)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
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).
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
NX1111 ( Other Identifier: company internal )
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Study Director: Bayer Study Director Bayer
January 2015