NCT00293124

Open-label Trial of GlivecWith Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors

An Open-label Trial of Glivec in Patients With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing C-kit.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Glivec	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

Timeline

• Start date: 2004-03-01
• Primary completion: 2006-07-01
• Completion: 2008-07-01
• First posted: 2006-02-17
• Last updated: 2015-08-13

Locations

16 sites across 10 countries: Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Lithuania, Romania, Serbia, Slovakia, Slovenia