Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244816
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2005-10-25
Brief Title:
Taxoprexin Treatment for Advanced Eye 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 Treatment of Patients With Metastatic Uveal Choroidal Malignant 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 choroidal 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 choroidal 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 choroidal melanoma who may be previously untreated or have received one prior systemic cytotoxic regimen for advanced disease Patients may not have been treated previously with taxanes 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