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NCT01459757 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01459757
Other study ID # A6181199
Secondary ID
Status Completed
Phase N/A
First received October 24, 2011
Last updated June 17, 2013
Start date October 2011
Est. completion date April 2013

Study information
Verified date June 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• non-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.

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  India,  Korea, Republic of,  Netherlands,  Poland,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome
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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