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Sponsored by: |
Viventia Biotech |
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Information provided by: | Viventia Biotech |
ClinicalTrials.gov Identifier: | NCT00412776 |
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.
Condition | Intervention | Phase |
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Advanced Squamous Cell Carcinoma of the Head and Neck Carcinoma, Squamous Cell Neoplasms, Squamous Cell Head and Neck Neoplasms Mouth Neoplasms Head and Neck Cancer |
Drug: Proxinium |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease |
Enrollment: | 165 |
Study Start Date: | December 2005 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Proxinium plus Best Supportive Care
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Drug: Proxinium
700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
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2: No Intervention
Best Supportive Care
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Disease Characteristics
Prior/Concurrent Therapy
Patient Characteristics
Other
• Women of childbearing potential and male patients must agree to use a highly effective contraceptive method.
Exclusion Criteria:
Study Director: | Wendy Cuthbert | Viventia Biotech Inc. |
Responsible Party: | Viventia Biotech Inc ( Wendy Cuthbert ) |
Study ID Numbers: | VB4-845-01-IIIA |
Study First Received: | December 14, 2006 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00412776 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Israel: Ministry of Health; Mexico: Federal Commission for Sanitary Risks Protection; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Poland: Ministry of Health; Germany: Paul-Ehrlich-Institut; India: Ministry of Health; Italy: Ministry of Health; Hungary: National Institute of Pharmacy; Romania: National Medicines Agency; Croatia: Ministry of Health and Social Care; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control |
Mouth Diseases Squamous cell carcinoma Mouth Neoplasms Carcinoma Epidermoid carcinoma Head and Neck Neoplasms Oral cancer |
Carcinoma, squamous cell Neoplasms, Squamous Cell Stomatognathic Diseases Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |