GISTNCT01459757
Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib
An observational study of GIST, run by Pfizer at 36 sites in 16 countries.
Trial summary
Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIST
- What is being tested?
- non-interventional
- How many people
- 322 participants
- Where
- 36 sitesin 16 countries
- Study dates
- Oct 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- GIST subjects that participated in the A6181036 study that had mutational status data analyzed.
Who cannot join
- Subjects not participating in the A6181036 study
Trial locations and contacts
36 sites in 16 countries.
36 sites in 16 countries
United States12 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
City of Hope
Duarte, California, 91010
Davis Cancer Pavilion and Shands Medical Plaza
Gainesville, Florida, 32608
Shands Cancer Hospital at the University of Florida
Gainesville, Florida, 32608
Shands Hospital at the University of Florida
Gainesville, Florida, 32608
Masonic Cancer Center - Clinical Trials Office
Minneapolis, Minnesota, 55455
Oregon Health and Science University
Portland, Oregon, 97239
Seattle Cancer Care Alliance
Seattle, Washington, 98109
University of Washington
Seattle, Washington, 98195
Moffitt Cancer Center
Tampa, Florida, 33612
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Australia3 sites
Peter MacCallum Cancer Institute, Department of Medical Oncology
East Melbourne, Victoria, 3002
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037
Prince of Wales Hospital, Oncology Day Center
Randwick, New South Wales, 2031
France3 sites
Institut Bergonie
Bordeaux, France, 33076
Centre L� B�rd
Lyon, Lyon Cedex, 69373
CHU La Timone, Service d'Oncologie Medicale
Marseille, France, 13385
Germany3 sites
HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie
Berlin, 13125
Klinikum der Universitaet zu Koeln
Cologne, 50937
Schwerpunktpraxis fuer ambulante Tumortherapie
Düsseldorf, 40212
South Korea2 sites
Seoul National University Hospital/Department of Internal Medicine
Seoul, 110-744
Asan Medical Center, Department of Internal Medicine
Seoul, 138-736
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41009
United Kingdom2 sites
Sarcoma Unit
London, SW3 6JJ
Christie Hospital NHS Trust
Manchester, M20 4BX
Canada1 site
Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal
Montreal, Quebec, H2L 4M1
Finland1 site
Helsingin yliopistollinen keskussairaala/Syopatautien klinikka
Helsinki, 00290
Netherlands1 site
Leids Universitair Medisch Centrum/ Klinische Oncologie
Leiden, Netherlands, 2333 ZA
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Lausanne, CH-1011
About this study
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
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
- Conditions
- GIST
- Being tested
- non-interventional
- Keywords
- Retrospective, GIST, sunitinib, mutational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Data generated from the past sunitinib A6181036 GIST study | Not described Receives: Other: non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GISTStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459757
- Sponsor's protocol ID
- A6181199
- Status last verified
- Jun 2013
- First submitted
- 24 Oct 2011
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01459757
- Acronym / sponsor ID
- A6181199
- Conditions
- GIST
- Keywords
- Retrospective, GIST, sunitinib, mutational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data generated from the past sunitinib A6181036 GIST study | – | Other: non-interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- GIST subjects that participated in the A6181036 study that had mutational status data analyzed.
Key exclusion criteria (1 listed)
- Subjects not participating in the A6181036 study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-interventionalNon-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. | Other | Data generated from the past sunitinib A6181036 GIST study |
Primary outcome
Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Derived from this study: PubMed 26772734Reichardt 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
36 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GIST, run by Pfizer at 36 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Australia, France, Germany, South Korea and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.