Prospective Multicentric Randomized Study of Glivec® in Advanced Gastrointestinal Stromal Tumors Expressing c-Kit: Interruption After 5 Years vs Maintenance

Prospective Multicentric Randomized Study of Glivec® in Advanced Gastrointestinal Stromal Tumors Expressing c-Kit: Interruption After 5 Years vs Maintenance

Gastrointestinal Stromal Tumor

Completed

3

Start Date 05/01/2002

Age of Trial (yrs) 22.6

First-line

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

CST1571BFR14, ET2002-021 BFR14

Centre Leon Berard, Institut Gustave Roussy

Jean Yves Blay, M.D, Ph.D

blay@lyon.fnclcc.fr

33607507064

Randomized

Oral

Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasability of Glivec® treatment interuption with reintroduction at progression in GIST patients.