Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096109
Status:
TERMINATED
Last Update Posted:
2017-01-16
First Post:
2004-11-09
Brief Title:
Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Clinical Trial of 17-Allyamino-17-Demethoxygeldanamycin 17-AAG in Chemotherapy Refractory Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed to accrual before all 12 planned patients were enrolled
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 tanespimycin works in treating women with refractory locally advanced or metastatic breast cancer Drugs used in chemotherapy such as tanespimycin work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rate of 17-Allylamino-17-Demethoxygeldanamycin 17-AAG tanespimycin in patients with refractoryresistant metastatic breast cancer
II To determine the progression free survival PFS of patients with refractoryresistant metastatic breast cancer when treated with 17-AAG
III To correlate patients her2neu status with response to 17-AAG treatment
OUTLINE This is a multicenter study
Patients receive tanespimycin IV over 1-6 hours on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at day 30 every 10-12 weeks until disease progression and then every 3 months thereafter
I To determine the response rate of 17-Allylamino-17-Demethoxygeldanamycin 17-AAG tanespimycin in patients with refractoryresistant metastatic breast cancer
II To determine the progression free survival PFS of patients with refractoryresistant metastatic breast cancer when treated with 17-AAG
III To correlate patients her2neu status with response to 17-AAG treatment
OUTLINE This is a multicenter study
Patients receive tanespimycin IV over 1-6 hours on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at day 30 every 10-12 weeks until disease progression and then every 3 months thereafter
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 |
|---|---|---|---|
| C-2803 | None | None | None |
| U01CA062502 | NIH | None | None |
| U01CA062487 | NIH | None | None |
| CDR0000391198 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062487 |