Study In Patients With Kidney Cancer Treated With Sutent

November 7, 2012 updated by: Pfizer

Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent

Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Pfizer Investigational Site
      • Bojnice, Slovakia, 972 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 812 50
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 10
        • Pfizer Investigational Site
      • Kosice, Slovakia, 043 91
        • Pfizer Investigational Site
      • Michalovce, Slovakia, 071 01
        • Pfizer Investigational Site
      • Nitra, Slovakia, 949 01
        • Pfizer Investigational Site
      • Poprad, Slovakia, 058 01
        • Pfizer Investigational Site
      • Presov, Slovakia, 081 81
        • Pfizer Investigational Site
      • Ruzomberok, Slovakia, 034 26
        • Pfizer Investigational Site
      • Trebisov, Slovakia, 075 01
        • Pfizer Investigational Site
      • Trencin, Slovakia, 911 71
        • Pfizer Investigational Site
      • Trnava, Slovakia, 917 75
        • Pfizer Investigational Site
      • Zilina, Slovakia, 012 07
        • Pfizer Investigational Site

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

Probability Sample

Study Population

Patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy.

Description

Inclusion Criteria:

  • Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy

Exclusion Criteria:

  • Hypersensitivity to sunitinib malate or to any of the excipients
  • Any other contraindication to the use of sunitinib malate (based on decision of the treating physician).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with Sutent
125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Drug: Sutent
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause
Other Names:
  • sunitinib malate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose modifications
Time Frame: 36 months
36 months
Incidence of new diagnosed hypertension
Time Frame: 36 months
36 months
Incidence of new diagnosed hypothyroidism
Time Frame: 36 months
36 months
Safety of sunitinib malate in "real-life" setting
Time Frame: 36 months
36 months
Efficacy of sunitinib malate in "real-life" setting
Time Frame: 36 months
36 months

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181185

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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