Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-03-01 @ 6:29 AM
Study NCT ID:
NCT00573404
Status:
TERMINATED
Last Update Posted:
2011-11-16
First Post:
2007-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VU-VICC-GI-0621 | None | None | View |