Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST) (07060)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Nilotinib in Advanced GIST Previously Treated With Imatinib and Sunitinib|
- Progression Free Survival Rate at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of participants that demonstrate progression free survival at 6 months
- Response Rate [ Time Frame: 1year ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
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.
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Margaret von Mehren, MD||Fox Chase Cancer Center|