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

June 2, 2019 updated by: Bayer

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Taiwanese patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients under daily life treatment according to local drug information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
After one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2010

Primary Completion (Actual)

June 8, 2012

Study Completion (Actual)

August 31, 2012

Study Registration Dates

First Submitted

August 12, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (Estimate)

September 6, 2010

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 2, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15242
  • NX1010TW (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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Locations

3
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