Open-Label Trial of Glivec With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors

Open-Label Trial of Glivec With Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumor

Completed

3

Start Date 03/01/2004

Age of Trial (yrs) 20.7

First-line

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

CSTI571BIC07

CECOG

Oral

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.