Spots Global Cancer Trial Database for Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
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Trial Identification
Brief Title: Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
Official Title: A Phase II, Non-Randomized, Open-Label Multicenter Study of 5 Year Adjuvant Imatinib Mesylate (Gleevec®) in Patients at Significant Risk for Recurrence Following Complete Resection of Primary Gastrointestinal Stromal Tumor (GIST)
Study ID: NCT00867113
Conditions
Interventions
Study Description
Brief Summary: This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST.
Detailed Description: This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The primary endpoint is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST. A total of 85 adult patients, 18 years of age and older will be enrolled.Participants will take 400 mg of imatinib mesylate daily by mouth for a total of 5 years. At the conclusion of the treatment period, patients will be followed for 2 years for survival, status of response and antineoplastic treatments and quality of life.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego - Moores Cancer Center Moores UCSD Cancer Center (31), La Jolla, California, United States
University of Colorado University of Colorado, Aurora, Colorado, United States
Washington Hospital Center Department of Medical Oncology, Washington, District of Columbia, United States
University Cancer & Blood Center, LLC, Athens, Georgia, United States
Longstreet Cancer Center, Gainesville, Georgia, United States
Kootenai Medical Center Kootenai Cancer Cancer, Coeur d'Alene, Idaho, United States
North Shore University Health System, Evanston, Illinois, United States
Dana Farber Cancer Institute Dana-Farber, Boston, Massachusetts, United States
Karmanos Cancer Institute Karmonos Cancer Instit. (40), Detroit, Michigan, United States
Washington University School of Medicine Center for Advanced Medicine, Saint Louis, Missouri, United States
Southern Nevada Cancer Research Foundation S. Nevada Cancer Res (2), Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (7), New York, New York, United States
Duke University Medical Center Duke University Med Ctr (8), Durham, North Carolina, United States
Oregon Health & Science University OHS University, Portland, Oregon, United States
Penn State University / Milton S. Hershey Medical Center Penn Stat University, Hershey, Pennsylvania, United States
Roger Williams Medical Center Medical Center, Providence, Rhode Island, United States
Kingport Hematology Oncology, Kingsport, Tennessee, United States
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (4), Houston, Texas, United States
South Texas Oncology and Hematology, PA South Texas Onc/Hem, San Antonio, Texas, United States
Virginia Oncology Associates Viriginia Oncology Assoc., Norfolk, Virginia, United States
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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