Trials / Terminated
TerminatedNCT00412776
Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
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
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Sesen Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Carcinoma, Squamous Cell of Head and Neck
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Mouth Neoplasms
- Head and Neck Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Proxinium | 700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2006-12-18
- Last updated
- 2015-12-23
Locations
122 sites across 18 countries: Argentina, Brazil, Croatia, France, Germany, Hungary, India, Israel, Italy, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00412776. Inclusion in this directory is not an endorsement.