CClinicalTrials.gg
CompletedNCT01459757Updated Jun 19, 2013

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

An observational study in GIST, sponsored by Pfizer. Completed at 36 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-19.

Sponsored by Pfizer · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
322
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • GIST

Keywords

  • Retrospective
  • GIST
  • sunitinib
  • mutational
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • GIST subjects that participated in the A6181036 study that had mutational status data analyzed.

Exclusion criteria

Exclusion Criteria:

  • Subjects not participating in the A6181036 study
05

Study design

Time perspective
Retrospective
Enrollment
322 participants (actual)

Groups and cohorts

  • Data generated from the past sunitinib A6181036 GIST study

    Other: non-interventional

Interventions

  • Othernon-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.

06

What researchers measure

Primary outcomes

  1. Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib

    Time frame: 9 months

07

Study locations

36 sites
  • City of Hope
    Duarte, California 91010, United States
  • Washington Hospital Center
    Washington, 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 Cedex, 33076, France
  • Centre L� B�rd
    Lyon Cedex, 69373, France
  • CHU La Timone, Service d'Oncologie Medicale
    Marseille, 13385, France
  • HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie
    Berlin, 13125, Germany
  • Schwerpunktpraxis fuer ambulante Tumortherapie
    Duesseldorf, 40212, Germany
  • Klinikum der Universitaet zu Koeln
    Koeln, 50937, Germany
  • Tata Memorial Centre
    Mumbai, Maharashtra 400012, India
  • Seoul National University Hospital/Department of Internal Medicine
    Seoul, 110-744, Korea, Republic of
  • Asan Medical Center, Department of Internal Medicine
    Seoul, 138-736, Korea, Republic of
  • Leids Universitair Medisch Centrum/ Klinische Oncologie
    Leiden, 2333 ZA, Netherlands
  • Klinika Nowotworow Tkanek Miekkich i Kosci
    Warszawa, 02-781, Poland
  • Narodny Onkologicky ustav
    Bratislava, 833 10, Slovakia
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08041, Spain
  • Hospital Universitario Virgen Macarena
    Sevilla, 41009, Spain
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, CH-1011, Switzerland
  • Sarcoma Unit
    London, SW3 6JJ, United Kingdom
  • Christie Hospital NHS Trust
    Manchester, M20 4BX, United Kingdom
08

References and documents

Publications

  • 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. PubMed 26772734 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01459757
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 26, 2011
Start date
Oct 2011
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Jun 19, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion