GIST Clinical Trial
Official title:
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
Verified date | June 2013 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.
Status | Completed |
Enrollment | 322 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Australia | Peter MacCallum Cancer Institute, Department of Medical Oncology | East Melbourne | Victoria |
Australia | Ashford Cancer Centre Research | Kurralta Park | South Australia |
Australia | Prince of Wales Hospital, Oncology Day Center | Randwick | New South Wales |
Belgium | UZ Leuven | Leuven | |
Canada | Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal | Montreal | Quebec |
Denmark | Herlev Hospital | Herlev | |
Finland | Helsingin yliopistollinen keskussairaala/Syopatautien klinikka | Helsinki | |
France | Institut Bergonie | Bordeaux Cedex | |
France | Centre L? B?rd | Lyon Cedex | |
France | CHU La Timone, Service d'Oncologie Medicale | Marseille | |
Germany | HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie | Berlin | |
Germany | Schwerpunktpraxis fuer ambulante Tumortherapie | Duesseldorf | |
Germany | Klinikum der Universitaet zu Koeln | Koeln | |
India | Tata Memorial Centre | Mumbai | Maharashtra |
Korea, Republic of | Asan Medical Center, Department of Internal Medicine | Seoul | |
Korea, Republic of | Seoul National University Hospital/Department of Internal Medicine | Seoul | |
Netherlands | Leids Universitair Medisch Centrum/ Klinische Oncologie | Leiden | |
Poland | Klinika Nowotworow Tkanek Miekkich i Kosci | Warszawa | |
Slovakia | Narodny Onkologicky ustav | Bratislava | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitario Virgen Macarena | Sevilla | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
United Kingdom | Sarcoma Unit | London | |
United Kingdom | Christie Hospital NHS Trust | Manchester | |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | City of Hope | Duarte | California |
United States | Davis Cancer Pavilion and Shands Medical Plaza | Gainesville | Florida |
United States | Shands Cancer Hospital at the University of Florida | Gainesville | Florida |
United States | Shands Hospital at the University of Florida | Gainesville | Florida |
United States | Masonic Cancer Center - Clinical Trials Office | Minneapolis | Minnesota |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | University of Washington | Seattle | Washington |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Korea, Republic of, Netherlands, Poland, Slovakia, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib | 9 months | No |
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