Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST)
- Conditions
- Gastrointestinal Stromal Tumors
- Registration Number
- NCT00782834
- Lead Sponsor
- Fox Chase Cancer Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression Free Survival Rate at 6 Months 6 months Number of participants that demonstrate progression free survival at 6 months
Response Rate 1year 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States