NCT00573404

Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors

A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Imatinib mesylate and sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate given together with sunitinib in treating patients with gastrointestinal stromal tumors.

Detailed description

OBJECTIVES: * 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 unacceptable toxicity. Blood samples are collected on day 15 and day 43 for pharmacokinetics. After completion of study treatment, patients are followed every 6 months.

Conditions

• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	imatinib mesylate	will start at 200 mg daily and will be escalated up to 400 mg bid.If the 400 mg bid dose is tolerated, no further dose escalation will be performed. In the case of excessive toxicity on the starting dose, the option for de-escalation is provided. Sunitinib will start at 25 mg daily and if tolerated, will be escalated to 37.5 mg daily for subsequent dose levels.
DRUG	sunitinib malate
OTHER	pharmacological study

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-09-01
• Completion: 2011-03-01
• First posted: 2007-12-14
• Last updated: 2011-11-16

Locations

3 sites across 1 country: United States