Trial Condition(s):
Carcinoma, Renal Cell
Nexavar as first targeted therapy in patients with advanced renal cell carcinoma (NEXTAR)
Bayer Identifier:
16091
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.
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).
Trial Summary
Enrollment Goal
20
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
NEXTAR - NEXavar® as first TARgeted treatment for patients with advanced Renal Cell Carcinoma
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Duration of Nexavar treatmentTimeframe: up to 3 years
Secondary Outcome
- Overall Survival (OS)Timeframe: 1 - 1.5 years after LPLV
- Health related quality of life (HRQoL)Timeframe: up to 3 years
- Progression-free survival (PFS)Timeframe: 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”.Timeframe: up to 3 years
- Incidence of Treatment-emergent Adverse Events (TEAE)Timeframe: up to 3 years
Additional Information
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