Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096668
Status:
COMPLETED
Last Update Posted:
2009-06-04
First Post:
2004-11-12
Brief Title:
Evaluation of Safety and Efficacy of TOCOSOLR Paclitaxel as Initial Treatment for Metastatic Breast Cancer
Sponsor:
Achieve Life Sciences
Organization:
Achieve Life Sciences
Study Overview
Official Title:
A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOLR Paclitaxel S-8184 Paclitaxel Injectable Emulsion as Initial Treatment of Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-06
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 is an open label study where each patient will receive TOCOSOLR Paclitaxel 120mgm2 every week for first line treatment of metastatic breast cancer Patients will be followed to determine the efficacy of treatment as measured by objective response rate and the safety associated with weekly administration of TOCOSOL Paclitaxel
Detailed Description:
This is an open label non-randomized Phase 2 study of weekly administration of TOCOSOL Paclitaxel at a dose level 120mgm2 known to be tolerated based on Phase 2a studies of this investigational agent in patients with other histological diagnoses This study is a fixed sample size design with no planned early stopping decision The goals of the study include the determination of the safety of TOCOSOL Paclitaxel and the objective response rate defined by RECIST criteria as complete responses plus partial responses
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