Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

PHASE3CompletedINTERVENTIONAL
Enrollment

248

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

June 30, 2011

Conditions
Gastrointestinal Stromal Tumors
Interventions
DRUG

Nilotinib

Nilotinib 400 mg twice daily (bid)

OTHER

Best Supportive Care (BSC) +/- imatinib or sunitinib

Can include pain medication, localized radiotherapy, nutritional support, and/or oxygen therapy and blood transfusions. Imatinib or sunitinib can be administered at the last tolerated dose and regimen or at the Investigator's choice.

Trial Locations (35)

3002

Novartis Investigative Site, East Melbourne

4066

Novartis Investigative Site, Auchenflower

10011

St. Vincent's Comprehensive Cancer Center, New York

33612

H. Lee Moffitt Cancer Center, Tampa

48201

Wayne State University/Wertz Clinical Cancer Center, Detroit

60637

University of Chicago Hospital, Chicago

63110

Washington University School of Medicine - Siteman Cancer Center, St Louis

90095

UCLA's Jonsson Comprehensive Cancer Center, Los Angeles

20010-2965

Washington Hospital Center - Washington Cancer Institute, Washington D.C.

02115

Dana Farber Cancer Institute, Boston

27157-1082

Wake Forest University Health Sciences, Winston-Salem

19111-2497

Fox Chase Cancer Center, Philadelphia

77030-4009

University of Texas/MD Anderson Cancer Center, Houston

Unknown

Novartis Investigative Site, Vienna

Novartis Investigative Site, Toronto

Novartis Investigative Site, Prague

Novartis Investigative Site, Bordeaux

Novartis Investigative Site, Lyon

Novartis Investigative Site, Marseille

Novartis Investigative Site, Berlin

Novartis Investigative Site, Cologne

Novartis Investigative Site, Düsseldorf

Novartis Investigative Site, Essen

Novartis Investigative Site, Frankfurt

Novartis Investigative Site, Hanover

Novartis Investigative Site, Mannheim

Novartis Investigative Site, München

Novartis Investigative Site, Tübingen

Novrtis Investigative Site, Bologna

Novartis Investigative Site, Milan

Novartis Investigative Site, Leiden

Novartis Investigative Site, Warsaw

Novartis Investigative Site, Seoul

Novartis Investigative Site, Madrid

Novartis Investigative Site, Chur

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY