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Brief Title: Open-label Trial of GlivecWith Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors
Official Title: An Open-label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing C-kit.
Study ID: NCT00293124
Brief Summary: The rationale is to assess the clinical and biological activity of Imatinib and to compare the data with historic data. Additionally this study has been designed to gain more experience with the treatment of GIST in several Central and Eastern European Countries.
Detailed Description: This is a multicenter open label clinical trial to be performed in patients with incurable malignant GISTs that are unresectable or metastatic. Approximately 150 patients will enter the trial. Patients will receive Imatinib 400 mg p.o./day for a period of up to 24 months provided that in the opinion of the investigator the patient is benefiting from treatment with Imatinib, and in the absence of any safety concerns. Treatment after completion of the 24 months study is at the discretion of the investigator. Imatinib should be increased to 600 mg p.o./day and then to 400 mg b.i.d if the patient is progressing on the respective dose level.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AKH, Universitätsklinik für Innere Medizin 1, Vienna, , Austria
Institute of Oncology Sarajevo, Sarajevo, , Bosnia and Herzegovina
SBALO National Oncology Center, Sofia, , Bulgaria
National Oncological Center Hospital, Sofia, , Bulgaria
Sofia Cancer Center compl. Mladost ,, Sofia, , Bulgaria
Clinical Hospital Split, Center of Oncology, Split, , Croatia
University Hospital Rebro, Zagreb, , Croatia
FN Bulovka, Prague, , Czech Republic
Radioterapeticko-onkologicke. Oddeleni FN Motol, Prague, , Czech Republic
Lithuanian Oncology Center,, Vilnius, , Lithuania
Institutul Oncologic Bucuresti, Bucuresti, , Romania
Institutul Oncologic Cluj, Cluj-Napoca, , Romania
Emergency Clinical County Hospital , Clin Oncol. Dep, Craiova, , Romania
Institut za onkologiju i, Beograd, , Serbia
National Institute of Oncology, Bratislava, , Slovakia
Oncology Institute Ljubljana, Ljubljana, , Slovenia
Name: Thomas Brodowicz, MD
Affiliation: University Clinic of Internal Medicine I / Clinical Oncology
Role: PRINCIPAL_INVESTIGATOR