Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193180
Status:
COMPLETED
Last Update Posted:
2016-05-27
First Post:
2005-09-12
Brief Title:
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-04
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 trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects
Detailed Description:
All patients in this study received docetaxel 30 mgm2 weekly for 3 consecutive weeks of each 28-day cycle along with continuous imatinib mesylate Initially imatinib mesylate was given at a dose of 600 mg orally daily beginning concurrently with the first dose of docetaxel however after the first 15 patients were treated it became evident that this imatinib dose was not tolerable and subsequent patients received imatinib mesylate 400 mg orally daily
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