Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412776
Status:
TERMINATED
Last Update Posted:
2015-12-23
First Post:
2006-12-14
Brief Title:
Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
Sponsor:
Sesen Bio Inc
Organization:
Sesen Bio Inc
Study Overview
Official Title:
A Randomized Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Corporate reasons unrelated to safety and efficacy
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 compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer
Detailed Description:
Head and neck cancer is a general description of a disease that includes several types of soft tissue carcinomas that develop in the head and neck regions
Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion molecule Ep-CAM that is highly expressed on squamous cell carcinomas of the head and neck SCCHN Proxinium is administered via intratumoural injection
The primary objective of the study is to compare the overall survival time for patients treated with intratumourally injected Proxinium plus BSC versus BSC alone Secondary objectives of the study include comparison of locoregional tumour control local progression-free survival symptomatic benefit and safety profile in patients who receive Proxinium plus BSC versus patients who receive BSC
Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion molecule Ep-CAM that is highly expressed on squamous cell carcinomas of the head and neck SCCHN Proxinium is administered via intratumoural injection
The primary objective of the study is to compare the overall survival time for patients treated with intratumourally injected Proxinium plus BSC versus BSC alone Secondary objectives of the study include comparison of locoregional tumour control local progression-free survival symptomatic benefit and safety profile in patients who receive Proxinium plus BSC versus patients who receive BSC
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