Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
NCT ID: NCT00867113
Last Updated: 2018-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2009-07-22
2016-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Imatinib
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
imatinib mesylate
imatinib mesylate was supplied in 100 and 400 mg tablets
Interventions
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imatinib mesylate
imatinib mesylate was supplied in 100 and 400 mg tablets
Eligibility Criteria
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Inclusion Criteria
2. Patient must have had a histological diagnosis of primary GIST.
3. The tumor must expressed KIT (CD117) protein by immunohistochemistry performed by central pathology.
4. Patient must have been at significant risk of tumor recurrence as defined by either:
* Primary GIST (any site): ≥ 2 cm and a mitotic rate of ≥ 5/50 HPF's
* Non-gastric primary GIST: ≥ 5cm
5. Patient must have undergone complete gross resection of a primary GIST within 12 weeks prior to first dose of imatinib study drug. The inclusion of R1 resections will be reviewed on a case by case basis by the Study Management Committee.
6. Patient must had no evidence of metastatic GIST on either 1) a post-operative CT of the abdomen and pelvis with intravenous and oral contrast or 2) MRI of the abdomen and pelvis with intravenous contrast. CT or MRI must have been performed within 8 weeks prior to first dose of imatinib study drug.
7. Performance status 0 or 1 (ECOG)
8. Patient must had the following post-operative laboratory values confirmed within 14 days prior to first dose of imatinib study drug:
* total bilirubin \< 1.5 x ULN NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study.
* ALT and AST \< 2.5 x ULN
* creatinine \< 1.5 x ULN
* ANC \> 1.5 x 109/L
* platelets \> 100 x 109/L
9. If patient is a cancer survivor, ALL of the following criteria apply:
* Patient had undergone potentially curative therapy for all prior malignancies.
* No evidence of any prior malignancies for at least 3 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone).
* Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
10. Female patients of childbearing potential must have had negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must have jagreed to employ an effective barrier method of birth control throughout the study and for up to 7 days following discontinuation of study drug.
11. Written, voluntary informed consent.
Exclusion Criteria
2. Prior treatment for GIST with the exception of prior treatment with imatinib adjuvant lasting ≤ 8 weeks following gross surgical resection.
3. Patient has received any other investigational agents within 28 days of first day of study drug dosing.
4. Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
5. Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risk or compromise compliance with the protocol (i.e., uncontrolled diabetes, chronic renal disease, chronic liver disease, or active uncontrolled infection).
6. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
7. Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin).
8. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
\-
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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 D.C., 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
St 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
Countries
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References
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Raut CP, Espat NJ, Maki RG, Araujo DM, Trent J, Williams TF, Purkayastha DD, DeMatteo RP. Efficacy and Tolerability of 5-Year Adjuvant Imatinib Treatment for Patients With Resected Intermediate- or High-Risk Primary Gastrointestinal Stromal Tumor: The PERSIST-5 Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e184060. doi: 10.1001/jamaoncol.2018.4060. Epub 2018 Dec 13.
Essat M, Cooper K. Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. Int J Cancer. 2011 May 1;128(9):2202-14. doi: 10.1002/ijc.25827.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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CSTI571BUS282
Identifier Type: -
Identifier Source: org_study_id
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