Trial Condition(s):
Carcinoma, Renal Cell
Advanced Renal Cell Carcinoma, with failure or unsuitable on prior interferon-alpha or interleukin-2 based therapy
Bayer Identifier:
15242
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The primary objective of this prospective, observational, post-marketing study is to evaluate the patient characteristics, pre-treatment and treatment duration in Renal Cell Carcinoma (RCC) patients who are candidates for systematic therapy and in whom a decision to treat with Nexavar® has been made under real-life practice settings and approved reimbursement restriction in Taiwan. Therefore, the main objective of the study is to collect data on:
Prescription pattern: to determine the factors affecting compliance and duration of treatment with special attention given to education status, demography, disease details, pre-treatment, concomitant medication and other baseline data
Nexavar® treatment and efficacy data
Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Inclusion Criteria
- Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Nexavar® under Taiwan reimbursement guideline - Patients must have a life expectancy of at least 8 weeks
Exclusion Criteria
- Exclusion criteria must follow the approved local product information. - Patients were lost to follow-up if no follow-up visit and no final assessment of Nexavar® was documented.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
Advanced Renal Cell Carcinoma, with failure or unsuitable on prior interferon-alpha or interleukin-2 based therapy
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Evaluation of Safety and Efficacy of treatments and average doses that are used for patients with Renal Cell Carcinoma (collection of number of adverse events)Timeframe: After one year
- Evaluation of Safety and Efficacy of treatments and average doses that are used for patients with Renal Cell Carcinoma (collection of changes in tumor status)Timeframe: After one year
Additional Information
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