Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST) — 07060  

Gastrointestinal Stromal Tumors Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

• NCT number: NCT00782834
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: July 2008
• Completion date: October 2009