stop_circleTerminated/Withdrawn

Carcinoma, Renal Cell

Bayer Identifier:

15242

ClinicalTrials.gov Identifier:

NCT01195649

EudraCT Number:

Not Available

EU CT Number:

Not Available
Advanced Renal Cell Carcinoma, with failure or unsuitable on prior interferon-alpha or interleukin-2 based therapy

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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 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
11
Trial Dates
December 2010 - August 2012
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

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)
    date_rangeTime Frame:
    After one year
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    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    After one year
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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