Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422877
Status:
TERMINATED
Last Update Posted:
2017-05-10
First Post:
2007-01-15
Brief Title:
Taxoprexin Treatment for Advanced Primary Cancers of the Liver
Sponsor:
American Regent Inc
Organization:
American Regent Inc
Study Overview
Official Title:
Phase II Open-Label Study of Weekly Taxoprexin DHA-paclitaxel Injection as Second Line Therapy for Patients With Advanced Primary Cancers of the Liver Including Hepatocellular Carcinoma and Carcinoma of the Gallbladder or Biliary Tract
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor suspended development of the drug on September 3 2008
Has Expanded Access:
False
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 primary liver cancer being treated with weekly Taxoprexin Injection
To explore the trough and peak blood levels of Taxoprexin and paclitaxel in these patients
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 primary liver cancer being treated with weekly Taxoprexin Injection
To explore the trough and peak blood levels of Taxoprexin and paclitaxel in these patients
Detailed Description:
This is a Phase II open-label study of weekly Taxoprexin Injection in patients with advanced primary cancers of the liver including hepatocellular carcinoma HCC or carcinoma of the gallbladder or biliary tract BTC who have not received prior systemic cytotoxic therapy for advanced disease Patients may have previously received radiation andor systemic chemotherapy as adjuvant therapy Patients may not have been treated previously with a taxane Patients may have been previously treated with up to two immunological andor biologic agents eg interferon monoclonal antibodies tyrosine kinase inhibitors Patients will receive Taxoprexin Injection at a dose of 500mgm2 400mgm2 for patients with an elevated bilirubin at baseline 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