Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST) (Novartis CSTI571BUS282)

Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST) (Novartis CSTI571BUS282)

Gastrointestinal Stromal Tumor

Completed

2

Start Date 06/01/2009

Age of Trial (yrs) 15.8

Adjuvant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

CSTI571BUS282

Novartis

Novartis

800-340-6843

Oral

This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The primary endpoint is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST. A total of 133 adult patients, 18 years of age and older will be enrolled.Participants will take 400 mg of imatinib mesylate daily by mouth for a total of 5 years. At the conclusion of the treatment period, patients will be followed for 5 years for survival, status of response, antineoplastic treatments and quality of life.