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Sponsored by: |
Central European Cooperative Oncology Group |
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Information provided by: | Central European Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00293124 |
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.
Condition | Intervention | Phase |
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Gastrointestinal Stromal Tumors |
Drug: Glivec |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing c-Kit. |
Estimated Enrollment: | 125 |
Study Start Date: | March 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
AKH, Universitätsklinik für Innere Medizin 1 | |
Vienna, Austria, 1090 | |
Bosnia and Herzegovina | |
Institute of Oncology Sarajevo | |
Sarajevo, Bosnia and Herzegovina | |
Bulgaria | |
SBALO National Oncology Center | |
Sofia, Bulgaria, 1527 | |
Sofia Cancer Center compl. Mladost , | |
Sofia, Bulgaria | |
National Oncological Center Hospital | |
Sofia, Bulgaria | |
Croatia | |
University Hospital Rebro | |
Zagreb, Croatia | |
Clinical Hospital Split, Center of Oncology | |
Split, Croatia | |
Czech Republic | |
FN Bulovka | |
Prague, Czech Republic, 186 00 | |
Radioterapeticko-onkologicke. Oddeleni FN Motol | |
Prague, Czech Republic | |
Lithuania | |
Lithuanian Oncology Center, | |
Vilnius, Lithuania | |
Romania | |
Institutul Oncologic Bucuresti | |
Bucuresti, Romania | |
Institutul Oncologic Cluj | |
Cluj-Napoca, Romania, 400015 | |
Emergency Clinical County Hospital , Clin Oncol. Dep | |
Craiova, Romania | |
Serbia and Montenegro | |
Institut za onkologiju i | |
Beograd, Serbia and Montenegro | |
Slovakia | |
National Institute of Oncology | |
Bratislava, Slovakia | |
Slovenia | |
Oncology Institute Ljubljana | |
Ljubljana, Slovenia |
Principal Investigator: | Thomas Brodowicz, MD | University Clinic of Internal Medicine I / Clinical Oncology |
Study ID Numbers: | CECOG/GIST 1.2.001, CSTI571BIC07 |
Study First Received: | February 16, 2006 |
Last Updated: | January 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00293124 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women |
Gastrointestinal Stromal Tumors Glivec |
Imatinib Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Protein Kinase Inhibitors |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Imatinib Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |