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

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ClinicalTrials.gov Identifier: NCT01508364
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Carcinoma, Renal Cell Drug: Sorafenib (Nexavar, BAY 43-9006)

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NEXTAR - NEXavar® as First TARgeted Treatment for Patients With Advanced Renal Cell Carcinoma
Study Start Date : July 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Duration of Nexavar treatment [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 1 - 1.5 years after LPLV ]
  2. Health related quality of life (HRQoL) [ Time Frame: up to 3 years ]
  3. Progression-free survival (PFS) [ Time Frame: up to 3 years ]
  4. 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 ]
  5. Incidence of Treatment-emergent Adverse Events (TEAE) [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508364


Locations
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01508364     History of Changes
Other Study ID Numbers: 16091
NX1111 ( Other Identifier: company internal )
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Bayer:
renal cell carcinoma, first targeted therapy, observational study

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action