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Sponsored by: |
Viventia Biotech |
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Information provided by: | Viventia Biotech |
ClinicalTrials.gov Identifier: | NCT00272181 |
The purpose of this study is to determine the safety, effectiveness, and recommended dose of Proxinium in North American patients with Squamous Cell Head and Neck Cancer
Condition | Intervention | Phase |
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Recurrent 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 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Proxinium 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: | 15 |
Study Start Date: | January 2006 |
Study Completion Date: | October 2007 |
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:
Exclusion Criteria:
Study Director: | Wendy Cuthbert | Viventia Biotech |
Study ID Numbers: | VB4-845-01-IIA |
Study First Received: | January 3, 2006 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00272181 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Mouth Diseases Carcinoma, Squamous Cell of Head and Neck Squamous Cell Carcinoma Mouth Neoplasms Recurrence Carcinoma Oral Cancer |
Head and Neck Neoplasms Epidermoid Carcinoma Neoplasms, Squamous Cell Stomatognathic Diseases Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Mouth Diseases Neoplasms Neoplasms by Site Neoplasms by Histologic Type Head and Neck Neoplasms Stomatognathic Diseases |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Mouth Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |