94
Participants
Start Date
June 30, 2009
Primary Completion Date
August 31, 2012
Study Completion Date
August 31, 2012
Nilotinib
Nilotinib hard gel capsules were supplied to the Investigators at dose strengths of 200 mg. Nilotinib is a novel agent, which has been approved for the treatment of chronic phase and accelerated phase Philadelphia-chromosome-positive CML in adult patients resistant to or intolerant to prior therapy that included imatinib.
Imatinib
Imatinib tablets were supplied at 100 mg and/or 400 mg dose strength. Imatinib is an approved agent for GIST. Efficacy of imatinib at a dose of 400 mg bid has been established in the setting of disease progression after the use of the conventional dose (400 mg qd).
Novartis Investigative Site, Caracas
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Khon Kaen
Novartis Investigative Site, Songkhla
Novartis Investigative Site, Beijing
Novartis Investigative Site, Moscow
Novartis Investigative Site, Saint Petersburg
Novartis Investigative Site, Shanghai
Novartis Investigative Site, Shanghai
Novartis Investigative Site, Guangzhou
Novartis Investigative Site, Guangzhou
Novartis Investigative Site, Chengdu
Novartis Investigative Site, Yekaterinburg
Novartis Investigative Site, Buenos Aires
Novartis Investigative Site, Caba
Novartis Investigative Site, Fortaleza
Novartis Investigative Site, Belo Horizonte
Novartis Investigative Site, Divinópolis
Novartis Investigative Site, Rio de Janeiro
Novartis Investigative Site, Natal
Novartis Investigative Site, Porto Alegre
Novartis Investigative Site, Porto Alegre
Novartis Investigative Site, Barretos
Novartis Investigative Site, São Paulo
Novartis Investigative Site, São Paulo
Novartis Investigative Site, Montreal
Novartis Investigative Site, Mexico City
Novartis Investigative Site, Hwasun-gun
Novartis Investigative Site, Daegu
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY