A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors
- To determine the maximum tolerated dose of imatinib mesylate in combination with
sunitinib malate in patients with gastrointestinal stromal tumors.
- To determine the toxicity of this regimen in these patients.
- To determine the antitumor activity in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral sunitinib malate once daily on days 1-14 in course 1 and on days 1-42
in all subsequent courses. Beginning in course 2, patients also receive oral imatinib
mesylate once or twice daily on days 1-42. Courses repeat every 6 weeks in the absence of
Blood samples are collected on day 15 and day 43 for pharmacokinetics.
After completion of study treatment, patients are followed every 6 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of imatinib mesylate in combination with sunitinib malate
at 6 weeks
Jordan D. Berlin, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GI 0621
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|