Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274456
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2006-01-10
Brief Title:
Phase II Trial Comparing ABI-007 Abraxane Nab-Paclitaxel to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Randomized Phase II Study of Weekly or Every 3 Weeks ABI-007 Versus Every 3 Weeks Taxotere as First Line Therapy of Stage IV Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-11
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 was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 Abraxane nab-paclitaxel to docetaxel Taxotere
Detailed Description:
This was an open-label randomized study to compare the following regimens with respect to toxicity and antitumor activity
the maximum tolerated dose MTD of ABI-007 300 mgm2 every 3 weeks
ABI-007 100 mgm2 administered weekly for 3 weeks with a 1 week rest
ABI-007 150 mgm2 administered weekly for 3 weeks with a 1 week rest
the standard dose and schedule of Taxotere 100 mgm2 every 3 weeks
the maximum tolerated dose MTD of ABI-007 300 mgm2 every 3 weeks
ABI-007 100 mgm2 administered weekly for 3 weeks with a 1 week rest
ABI-007 150 mgm2 administered weekly for 3 weeks with a 1 week rest
the standard dose and schedule of Taxotere 100 mgm2 every 3 weeks
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