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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
400 mg orally twice daily until disease progression, intolerability or withdrawal of consent
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Progression Free Survival Rate at 6 Months
Number of participants that demonstrate progression free survival at 6 months
Time frame: 6 months
Response Rate
Response rate of nilotinib by RECIST criteria evaluated every 2 months for the first 6 months then every 3 months for the duration of treatment period.
Time frame: 1year
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