Efficacy and Safety of AMN107 Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib - Extension

Efficacy and Safety of AMN107 Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib - Extension

Gastrointestinal Stromal Tumor

Completed

3

Start Date 05/01/2007

Age of Trial (yrs) 17.6

Extension Study

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

CAMN107A2201E1 (ENEST)

Novartis

Novartis

800 340 6843

Randomized

Oral

AMN107 is manufactured by Novartis. AMN107 is a newer and possibly more potent tyrosine kinase inhibitor. Like Gleevec, it also inhibits KIT, PDGFRA, and BCR/ABL. Phase III trials began in late April of 2007 and as of 4/7/08 have reached accrual goals.
The phase III trial is for patients that are resistant (or intolerant) to both Gleevec and Sutent. Patients were randomized to receive either AMN107 or best supportive care. For every patient that received best supportive care, two patients received AMN107. Best supportive care allows the treating physician to continue administering Gleevec, Sutent, or other supporting care. Patients receiving best supportive care will be allowed to cross over to receive AMN107 at the time of progression. Patients receiving AMN107 will be given 400 mg twice a day (800 mg total).