Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-29 @ 8:15 PM
Study NCT ID:
NCT00274456
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2006-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
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:
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 mg/m\^2 every 3 weeks;
* ABI-007 100 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* ABI-007 150 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* the standard dose and schedule of Taxotere (100 mg/m\^2 every 3 weeks).
* the maximum tolerated dose (MTD) of ABI-007 300 mg/m\^2 every 3 weeks;
* ABI-007 100 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* ABI-007 150 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* the standard dose and schedule of Taxotere (100 mg/m\^2 every 3 weeks).
Study Oversight
Has Oversight DMC:
False
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?: