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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
400mg p.o./day in a population of patients with locally advanced (=not amenable to surgery with curative intent) or metastatic malignant GIST. Glivec® may be increased to 600 mg p.o./day and then 800 mg p.o./day (400 mg b.i.d.) if the patient is progressing
AKH, Universitätsklinik für Innere Medizin 1
Vienna, Austria
Institute of Oncology Sarajevo
Sarajevo, Bosnia and Herzegovina
SBALO National Oncology Center
Time to Disease Progression
Time frame: until PD
Time to Disease Progression
Time frame: until PD
Overall Survival
Time frame: until death
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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, Czechia
Radioterapeticko-onkologicke. Oddeleni FN Motol
Prague, Czechia
Lithuanian Oncology Center,
Vilnius, Lithuania
...and 6 more locations