Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199212
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2005-09-13
Brief Title:
PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2
Sponsor:
Jules Bordet Institute
Organization:
Jules Bordet Institute
Study Overview
Official Title:
A Phase I Open Label Dose-escalating Study of the Proteasome Inhibitor PS-341 in Combination With Two Schedules of Herceptin in Patients With Advanced Breast Cancer That Overexpresses HER-2
Status:
COMPLETED
Status Verified Date:
2011-02
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:
The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib PS-341 Velcade with trastuzumab Herceptin and to determine the best dose of bortezomib to combine with two trastuzumab schedules weekly and 3-weekly
Detailed Description:
Phase 1 study to determine the feasibility of the combination of the proteasome inhibitor bortezomib PS-341 Velcade with trastuzumab Herceptin given either weekly or 3-weekly
Additionally hints about efficacy of the combination will be looked upon
Additionally hints about efficacy of the combination will be looked upon
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