Advanced Renal Cell Carcinoma, With Failure or Unsuitable on Prior Interferon-alpha or Interleukin-2 Based Therapy

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 8, 2012

Interventions

  • Drug: Sorafenib (Nexavar, BAY43-9006)
    • Patients under daily life treatment according to local drug information

Arms, Groups and Cohorts

  • Group 1

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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