Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib

June 17, 2013 updated by: Pfizer

A Non-Interventional Retrospective Correlation Of Tumor Mutation Status To Clinical Benefit From The SU011248, A6181036 Treatment Protocol Titled: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a non-interventional trial. No active patients will participate in this study. Only data generated from the A6181036 study will be utilized for correlational purposes. The A6181036 study data in addition to mutational status data previously analyzed but not collected as part of the A6181036 study in the same patient population

Study Type

Observational

Enrollment (Actual)

322

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

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital, Oncology Day Center
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre Research
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Institute, Department of Medical Oncology
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital
  • Finland
      • Helsinki, Finland, 00290
        • Helsingin yliopistollinen keskussairaala/Syopatautien klinikka
  • France
      • Bordeaux Cedex, France, 33076
        • Institut Bergonie
      • Lyon Cedex, France, 69373
        • Centre L� B�rd
      • Marseille, France, 13385
        • CHU La Timone, Service d'Oncologie Medicale
  • Germany
      • Berlin, Germany, 13125
        • HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie
      • Duesseldorf, Germany, 40212
        • Schwerpunktpraxis fuer ambulante Tumortherapie
      • Koeln, Germany, 50937
        • Klinikum der Universitaet zu Koeln
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Centre
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital/Department of Internal Medicine
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, Department of Internal Medicine
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum/ Klinische Oncologie
  • Poland
      • Warszawa, Poland, 02-781
        • Klinika Nowotworow Tkanek Miekkich i Kosci
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Narodny Onkologicky Ustav
  • Spain
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Sarcoma Unit
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Trust
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Gainesville, Florida, United States, 32608
        • Shands Cancer Hospital at the University of Florida
      • Gainesville, Florida, United States, 32608
        • Davis Cancer Pavilion and Shands Medical Plaza
      • Gainesville, Florida, United States, 32608
        • Shands Hospital at the University of Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center - Clinical Trials Office
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington

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

Clinical outcomes data generated from the sunitinib A6181036 study in GIST correlated with mutational status data previously analyzed for the same patients but not collected as part of the A6181036 study.

Description

Inclusion Criteria:

  • GIST subjects that participated in the A6181036 study that had mutational status data analyzed.

Exclusion Criteria:

  • Subjects not participating in the A6181036 study

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
Data generated from the past sunitinib A6181036 GIST study
Other: non-interventional
Non-interventional; Mutational status data analyzed previously but not collected in the A6181036 study, will be correlated wth A6181036 clinical outcomes data collected during the A6181036 study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib
Time Frame: 9 months
9 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.

General Publications

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

October 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (ESTIMATE)

October 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A6181199

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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