Conditions: Gastrointestinal Stromal Tumor (GIST)
Keywords: Unresectable GIST metastatic GIST nilotinib AMN107 imatinib STI571
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 644
Healthy volunteers: no

Brief summary:
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Detailed description:

Arms:
arm 1: nilotinib 400 mg twice a day arm 2: imatinib 400 mg once daily

Interventions: intervention 1: Nilotinib (AMN107) intervention 2: imatinib (STI571)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: