Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041340
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2002-07-08
Brief Title:
Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of Gleevec Imatinib Mesylate Formerly Known AsSTI571 NSC 716051 In Patients With Colorectal Cancer Stage IV
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine response to Gleevec Imatinib Mesylate in patients with metastatic colorectal cancer and with c-Kit Arg Abl or PDGF-R expression
II To determine the side effects of Imatinib Mesylate in patients with colorectal cancer
III To study the biologic effects of Imatinib Mesylate on the c-Kit and PDGF-R system and downstream signaling in metastatic colorectal cancer
OUTLINE
Patients receive oral imatinib mesylate twice daily Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity Patients with stable disease or better continue therapy until disease progression or 1 year after complete response
I To determine response to Gleevec Imatinib Mesylate in patients with metastatic colorectal cancer and with c-Kit Arg Abl or PDGF-R expression
II To determine the side effects of Imatinib Mesylate in patients with colorectal cancer
III To study the biologic effects of Imatinib Mesylate on the c-Kit and PDGF-R system and downstream signaling in metastatic colorectal cancer
OUTLINE
Patients receive oral imatinib mesylate twice daily Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity Patients with stable disease or better continue therapy until disease progression or 1 year after complete response
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069475 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62202 |
| ID01-557 | None | None | None |
| N01CM62202 | NIH | None | None |