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

Completed

• Conditions: GIST

• Registration Number: NCT01459757
• Lead Sponsor: Pfizer

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

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-26
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib	9 months

Trial Locations

Locations (36)

City of Hope; 🇺🇸 Duarte, California, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, 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

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Masonic Cancer Center - Clinical Trials Office; 🇺🇸 Minneapolis, Minnesota, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

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