Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST Nilotinib
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
This is a phase II study of Nilotinib for patients with advanced GIST that cannot be surgically removed. Patients are candidates for the study if their tumors have progressed on imatinib and sunitinib or if they were intolerant to these drugs. Patients may have received other investigational therapies as well. We are testing the benefit of nilotinib in advanced GIST looking at the length of time disease is controlled as well as the response of the disease to the drug.

Detailed description:
Nilotinib is an oral drug. The dose is 400 mg twice daily

Patients are evaluated every 8 weeks for disease response. Blood work is assessed for safety initially weekly, then every 4 weeks. Physical exams are performed initially weekly and then decreased to every 4 weeks after the first month.

Arms:

Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: 400 mg orally twice daily until disease progression, intolerability or withdrawal of consent

Protocol document: