Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098397
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2004-12-07
Brief Title:
FR901228 in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Single Agent Depsipeptide FK228 In 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:
This phase II trial is studying how well FR901228 works in treating patients with metastatic breast cancer Drugs used in chemotherapy such as FR901228 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy and safety of FR901228 depsipeptide in patients with metastatic breast cancer
SECONDARY OBJECTIVES
I Determine the clinical activity of this drug in terms of progression-free survival in these patients
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 24-123 months
I Determine the efficacy and safety of FR901228 depsipeptide in patients with metastatic breast cancer
SECONDARY OBJECTIVES
I Determine the clinical activity of this drug in terms of progression-free survival in these patients
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 24-123 months
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 |
|---|---|---|---|
| MDA-2003-0895 | None | None | None |
| N01CM17003 | NIH | None | None |
| CDR0000404163 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |