Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST adults imatinib resistant sunitinib resistant AMN107 nilotinib treatment Gastrointestinal stromal tumor (GIST)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 248
Healthy volunteers: no

Brief summary:
The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.

Detailed description:

Arms:
arm 1: 400mg twice daily in core and extension phases of the study. arm 2: In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.

Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression.

Interventions: intervention 1: Nilotinib intervention 2: Best Supportive Care (BSC) +/- imatinib or sunitinib
Intervention descriptions: intervention 1: Nilotinib 400 mg twice daily (bid) intervention 2: 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.

Protocol document: