Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496379
Status:
TERMINATED
Last Update Posted:
2013-03-14
First Post:
2007-07-03
Brief Title:
ZK219477 Sagopilone in Patients With Breast Cancer and Brain Metastases
Sponsor:
Nancy Lin MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 2 Study of ZK219477 ZK-EPO in Patients With Breast Cancer and Brain Metastases
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has closed to accrual early due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine the effects good and bad of ZK219477sagopilone on participants and their cancer ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide It is a part of a group of drugs called epothilones which appear to cause shrinkage of cancer in some patients with breast cancer It is generally difficult for chemotherapy to enter the brain However it is believed that ZK219477 crosses into the brain We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477
Detailed Description:
Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks
During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed
At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body
After every 2 cycles of treatment participants will have additional scans to assess the effect of ZK219477 on their cancer This will include a CT scan of the abdomen chest and pelvis and an MRI of the brain
At the time of the standard MRI participants will be asked to undergo an additional MRI sequence which means they will be in the MRI machine for approximately 15-20 more minutes
During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed
At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body
After every 2 cycles of treatment participants will have additional scans to assess the effect of ZK219477 on their cancer This will include a CT scan of the abdomen chest and pelvis and an MRI of the brain
At the time of the standard MRI participants will be asked to undergo an additional MRI sequence which means they will be in the MRI machine for approximately 15-20 more minutes
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