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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Bergonié
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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