Advanced Renal Cell Carcinoma, With Failure or Unsuitable on Prior Interferon-alpha or Interleukin-2 Based Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Sorafenib (Nexavar, BAY43-9006)
- Conditions
- Carcinoma, Renal Cell
- Sponsor
- Bayer
- Enrollment
- 11
- Primary Endpoint
- 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)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group 1
Intervention: Sorafenib (Nexavar, BAY43-9006)
Outcomes
Primary Outcomes
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)
Time Frame: After one year
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)
Time Frame: After one year