NCT00782834

Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST)

Evaluation of Nilotinib in Advanced GIST Previously Treated With Imatinib and Sunitinib

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Nilotinib	400 mg orally twice daily until disease progression, intolerability or withdrawal of consent

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-07-01
• Completion: 2009-10-01
• First posted: 2008-10-31
• Last updated: 2013-04-22
• Results posted: 2011-08-29

Locations

1 site across 1 country: United States