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

NCT ID: NCT01459757

Last Updated: 2013-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-04-30

Brief Summary

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

Detailed Description

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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

Conditions

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GIST

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Data generated from the past sunitinib A6181036 GIST study

non-interventional

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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City of Hope

Duarte, California, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Davis Cancer Pavilion and Shands Medical Plaza

Gainesville, Florida, United States

Site Status

Shands Cancer Hospital at the University of Florida

Gainesville, Florida, United States

Site Status

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Masonic Cancer Center - Clinical Trials Office

Minneapolis, Minnesota, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Prince of Wales Hospital, Oncology Day Center

Randwick, New South Wales, Australia

Site Status

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Site Status

Peter MacCallum Cancer Institute, Department of Medical Oncology

East Melbourne, Victoria, Australia

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal

Montreal, Quebec, Canada

Site Status

Herlev Hospital

Herlev, , Denmark

Site Status

Helsingin yliopistollinen keskussairaala/Syopatautien klinikka

Helsinki, , Finland

Site Status

Institut Bergonie

Bordeaux, France, France

Site Status

CHU La Timone, Service d'Oncologie Medicale

Marseille, France, France

Site Status

Centre L� B�rd

Lyon, Lyon Cedex, France

Site Status

HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie

Berlin, , Germany

Site Status

Klinikum der Universitaet zu Koeln

Cologne, , Germany

Site Status

Schwerpunktpraxis fuer ambulante Tumortherapie

Düsseldorf, , Germany

Site Status

Tata Memorial Centre

Mumbai, Maharashtra, India

Site Status

Leids Universitair Medisch Centrum/ Klinische Oncologie

Leiden, Netherlands, Netherlands

Site Status

Klinika Nowotworow Tkanek Miekkich i Kosci

Warsaw, Poland, Poland

Site Status

Narodny Onkologicky ustav

Bratislava, , Slovakia

Site Status

Seoul National University Hospital/Department of Internal Medicine

Seoul, , South Korea

Site Status

Asan Medical Center, Department of Internal Medicine

Seoul, , South Korea

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, Lausanne, Switzerland

Site Status

Sarcoma Unit

London, , United Kingdom

Site Status

Christie Hospital NHS Trust

Manchester, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada Denmark Finland France Germany India Netherlands Poland Slovakia South Korea Spain Switzerland United Kingdom

References

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Reichardt P, Demetri GD, Gelderblom H, Rutkowski P, Im SA, Gupta S, Kang YK, Schoffski P, Schuette J, Soulieres D, Blay JY, Goldstein D, Fly K, Huang X, Corsaro M, Lechuga MJ, Martini JF, Heinrich MC. Correlation of KIT and PDGFRA mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial. BMC Cancer. 2016 Jan 15;16:22. doi: 10.1186/s12885-016-2051-5.

Reference Type DERIVED
PMID: 26772734 (View on PubMed)

Related Links

Other Identifiers

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A6181199

Identifier Type: -

Identifier Source: org_study_id

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