A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors
NCT ID: NCT00940563
Last Updated: 2011-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2002-03-31
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
Imatinib
Interventions
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Imatinib
Eligibility Criteria
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Inclusion Criteria
2. Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
3. Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
4. At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
5. Performance status 0,1, 2 or 3 (ECOG).
6. Adequate end organ function.
7. Adequate bone marrow function.
8. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
Exclusion Criteria
2. Other primary malignancy with \< 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
3. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
4. Pregnancy, breast-feeding.
5. Severe and/or uncontrolled medical disease.
6. Known brain metastasis.
7. Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
8. Known diagnosis of human immunodeficiency virus (HIV) infection.
9. Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
10. Previous radiotherapy to ≥ 25 % of the bone marrow.
11. Major surgery within 2 weeks prior to study entry.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Ancona, , Italy
Novartis Investigative Site
Aviano, , Italy
Novartis Investigative Site
Bari, , Italy
Novartis Investigative Site
Bergamo, , Italy
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Candiolo, , Italy
Novartis Investigative Site
Ferrara, , Italy
Novartis Investigative Site
Florence, , Italy
Novartis Investigative Site
Genova, , Italy
Novartis Investigative Site
Livorno, , Italy
Novartis Investigative Site
Meldola, , Italy
Novartis Investigative Site
Messina, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Monserrato, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Nola, , Italy
Novartis Investigative Site
Padua, , Italy
Novartis Investigative Site
Palermo, , Italy
Novartis Investigative Site
Perugia, , Italy
Novartis Investigative Site
Pisa, , Italy
Novartis Investigative Site
Ravenna, , Italy
Novartis Investigative Site
Roma, , Italy
Novartis Investigative Site
Rozzano, , Italy
Novartis Investigative Site
Sassari, , Italy
Novartis Investigative Site
Torino, , Italy
Novartis Investigative Site
Verona, , Italy
Countries
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Other Identifiers
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CSTI571BIT03
Identifier Type: -
Identifier Source: org_study_id
NCT00942279
Identifier Type: -
Identifier Source: nct_alias
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