Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib
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
1 other identifier
observational
322
16 countries
36
Brief Summary
Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJune 19, 2013
June 1, 2013
1.5 years
October 24, 2011
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib
9 months
Study Arms (1)
Data generated from the past sunitinib A6181036 GIST study
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- GIST subjects that participated in the A6181036 study that had mutational status data analyzed.
You may not qualify if:
- Subjects not participating in the A6181036 study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (36)
City of Hope
Duarte, California, 91010, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Davis Cancer Pavilion and Shands Medical Plaza
Gainesville, Florida, 32608, United States
Shands Cancer Hospital at the University of Florida
Gainesville, Florida, 32608, United States
Shands Hospital at the University of Florida
Gainesville, Florida, 32608, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Masonic Cancer Center - Clinical Trials Office
Minneapolis, Minnesota, 55455, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington
Seattle, Washington, 98195, United States
Prince of Wales Hospital, Oncology Day Center
Randwick, New South Wales, 2031, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Peter MacCallum Cancer Institute, Department of Medical Oncology
East Melbourne, Victoria, 3002, Australia
UZ Leuven
Leuven, 3000, Belgium
Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal
Montreal, Quebec, H2L 4M1, Canada
Herlev Hospital
Herlev, 2730, Denmark
Helsingin yliopistollinen keskussairaala/Syopatautien klinikka
Helsinki, 00290, Finland
Institut Bergonie
Bordeaux, France, 33076, France
CHU La Timone, Service d'Oncologie Medicale
Marseille, France, 13385, France
Centre L� B�rd
Lyon, Lyon Cedex, 69373, France
HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie
Berlin, 13125, Germany
Klinikum der Universitaet zu Koeln
Cologne, 50937, Germany
Schwerpunktpraxis fuer ambulante Tumortherapie
Düsseldorf, 40212, Germany
Tata Memorial Centre
Mumbai, Maharashtra, 400012, India
Leids Universitair Medisch Centrum/ Klinische Oncologie
Leiden, Netherlands, 2333 ZA, Netherlands
Klinika Nowotworow Tkanek Miekkich i Kosci
Warsaw, Poland, 02-781, Poland
Narodny Onkologicky ustav
Bratislava, 833 10, Slovakia
Seoul National University Hospital/Department of Internal Medicine
Seoul, 110-744, South Korea
Asan Medical Center, Department of Internal Medicine
Seoul, 138-736, South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41009, Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, Lausanne, CH-1011, Switzerland
Sarcoma Unit
London, SW3 6JJ, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
Related Publications (1)
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.
PMID: 26772734DERIVED
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 26, 2011
Study Start
October 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
June 19, 2013
Record last verified: 2013-06