Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045188
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2002-09-06
Brief Title:
Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of STI571 in Metastatic Breast Cancer
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 metastatic breast cancer Imatinib mesylate may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of STI571 in metastatic breast cancer MBC that demonstrates expression of CD117 c-kit and or PDGFR
SECONDARY OBJECTIVES
I To determine the clinical activity of STI571 in MBC with expression of CD117 ckit and or PDGFR by evaluating progression-free survival PFS
II To determine the toxicity profile and tolerability of STI571 in patients with MBC
III To define serum tissue and imaging surrogate endpoints of activity of STI571 in MBC
OUTLINE
Patients receive oral imatinib mesylate twice daily Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity
I To determine the efficacy of STI571 in metastatic breast cancer MBC that demonstrates expression of CD117 c-kit and or PDGFR
SECONDARY OBJECTIVES
I To determine the clinical activity of STI571 in MBC with expression of CD117 ckit and or PDGFR by evaluating progression-free survival PFS
II To determine the toxicity profile and tolerability of STI571 in patients with MBC
III To define serum tissue and imaging surrogate endpoints of activity of STI571 in MBC
OUTLINE
Patients receive oral imatinib mesylate twice daily Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000256915 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |
| IDO1-691 | None | None | None |
| N01CM17003 | NIH | None | None |