Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249262
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2005-11-03
Brief Title:
Taxoprexin Treatment for Advanced Skin Melanoma
Sponsor:
American Regent Inc
Organization:
American Regent Inc
Study Overview
Official Title:
Phase II Open-Label Study of Weekly Taxoprexin DHA-paclitaxel Injection as First Line Treatment of Patients With Metastatic Non-choroidal Melanoma
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate objective response rate and duration of response to weekly Taxoprexin
To evaluate the safety profile of weekly Taxoprexin in this patient population
To evaluate overall survival in the same patient population To evaluate time to disease progression and the time to treatment failure in patients with metastatic malignant melanoma being treated with weekly Taxoprexin Injection
To evaluate the safety profile of weekly Taxoprexin in this patient population
To evaluate overall survival in the same patient population To evaluate time to disease progression and the time to treatment failure in patients with metastatic malignant melanoma being treated with weekly Taxoprexin Injection
Detailed Description:
This is a Phase II open-label study of weekly Taxoprexin Injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease Patients may have been previously treated with immunological agents including IL-2 and vaccines Patients will receive Taxoprexin Injection at a dose of 500mgm2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle Treatment will continue until progression of disease intolerable toxicity refusal of continued treatment by patient or Investigator decision
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