Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT00573404
Brief 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.
Study:
NCT00573404
Study Brief:
Protocol Section:
NCT00573404