Clinical trial NCT01459757: Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GIST
Keywords: Retrospective
GIST
sunitinib
mutational
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: Davis Cancer Pavilion and Shands Medical Plaza
state: Florida
city: Gainesville
country: United States
facility: Shands Cancer Hospital at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Minneapolis
country: United States
facility: Masonic Cancer Center - Clinical Trials Office
state: Minnesota
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Randwick
country: Australia
facility: Prince of Wales Hospital, Oncology Day Center
state: New South Wales
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute, Department of Medical Oncology
state: Victoria
city: Leuven
country: Belgium
facility: UZ Leuven
city: Montreal
country: Canada
facility: Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal
state: Quebec
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala/Syopatautien klinikka
city: Bordeaux Cedex
country: France
facility: Institut Bergonie
city: Lyon Cedex
country: France
facility: Centre L� B�rd
city: Marseille
country: France
facility: CHU La Timone, Service d'Oncologie Medicale
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie
city: Duesseldorf
country: Germany
facility: Schwerpunktpraxis fuer ambulante Tumortherapie
city: Koeln
country: Germany
facility: Klinikum der Universitaet zu Koeln
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital/Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Department of Internal Medicine
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum/ Klinische Oncologie
city: Warszawa
country: Poland
facility: Klinika Nowotworow Tkanek Miekkich i Kosci
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky ustav
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: London
country: United Kingdom
facility: Sarcoma Unit
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.