Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148707
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2005-09-07
Brief Title:
Study of Xyotax CT-2103 in Patients With Metastatic Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to collect information on what effects good or bad CT-2103 Xyotax has on breast cancer as well as any side effects the drug may cause
Detailed Description:
Patients will be given CT-2103 intravenously every 3 weeks One week after the first dose of CT-2103 a physical exam blood work and assessment of any side effects will be performed
Prior to each injection of CT-2103 a physical exam blood work and assessment of any side effects will be performed every 3 weeks
Every 6 weeks the patients cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working
Additional blood work will be performed once per week after the first two doses of CT-2103
The participation in this study will last at least 2 cycles 6 weeks however patients may remain on the study as long as there is no disease progression and they are able to tolerate the study drug without severe side effects
Prior to each injection of CT-2103 a physical exam blood work and assessment of any side effects will be performed every 3 weeks
Every 6 weeks the patients cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working
Additional blood work will be performed once per week after the first two doses of CT-2103
The participation in this study will last at least 2 cycles 6 weeks however patients may remain on the study as long as there is no disease progression and they are able to tolerate the study drug without severe side effects
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