Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140140
Status:
TERMINATED
Last Update Posted:
2019-11-26
First Post:
2005-08-30
Brief Title:
A Phase III Study of ABI-007 Abraxane Nab-Paclitaxeland Vinorelbine in Patients With Stage IV Metastatic Breast Cancer
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
An Open-Label Phase III Study of Weekly ABI-007 and Vinorelbine With or Without G-CSF in Patients With Stage IV Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to determine the optimum tolerated dose
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to 1 determine the optimal tolerated dose of ABI-007 and vinorelbine given concurrently on a weekly basis in the absence of planned growth factor support with granulocyte colony-stimulating factor G-CSF Patients with HER-2neu positive disease may receive Herceptin and 2 determine the optimal tolerated dose of ABI-007 and vinorelbine given concurrently on a weekly basis in the presence of planned growth factor support with G-CSF
Detailed Description:
None
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