Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025584
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2001-10-11
Brief Title:
PS-341 in Treating Women With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial Of PS-341 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:
PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of PS-341 in terms of response rate in women with metastatic breast cancer
SECONDARY OBJECTIVES
I Determine the clinical activity of this drug in terms of progression-free survival in these women
II Determine the toxicity profile and tolerability of this drug in these women
III Determine the pharmacodynamics of this drug in these women
OUTLINE
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A maximum of 12-35 patients will be accrued for this study within 9-12 months
I Determine the efficacy of PS-341 in terms of response rate in women with metastatic breast cancer
SECONDARY OBJECTIVES
I Determine the clinical activity of this drug in terms of progression-free survival in these women
II Determine the toxicity profile and tolerability of this drug in these women
III Determine the pharmacodynamics of this drug in these women
OUTLINE
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A maximum of 12-35 patients will be accrued for this study within 9-12 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 |
|---|---|---|---|
| CDR0000068976 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |
| ID00-308 | None | None | None |
| N01CM17003 | NIH | None | None |