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Sponsored by: |
Viventia Biotech |
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Information provided by: | Viventia Biotech |
ClinicalTrials.gov Identifier: | NCT00481936 |
The purpose of this study is to determine the maximum tolerated dose (MTD) of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion to patients with advanced solid tumour of epithelial origin.
Condition | Intervention | Phase |
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Neoplasms, Glandular and Epithelial |
Drug: VB6-845 |
Phase I |
Study Type: | Interventional |
Study Design: | Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Escalating Dose Study of VB6-845, a Recombinant Fusion Protein Targeting EpCAM, in Patients With Advanced Solid Tumours of Epithelial Origin |
Enrollment: | 15 |
Study Start Date: | May 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Disease Characteristics:
Patient Characteristics:
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and life expectancy
Other:
Exclusion Criteria:
Georgia | |
Chemotherapy and Immunotherapy clinic Medulla | |
Tbilisi, Georgia | |
Russian Federation | |
Blokhin Cancer Research Centre, Department of Clinical Pharmacology and Chemotherapy | |
Moscow, Russian Federation | |
Blokhin Cancer Research Centre, Department of Chemotherapy and Combined therapy | |
Moscow, Russian Federation | |
Yaroslavi Regional Clinical Oncology Hospital | |
Yaroslav, Russian Federation | |
Non state Institution of Ministry of Health "Central Clinical Hospital #2 named after N.A. Semashko" of Open-joint stock company "Russian Railways" | |
Moscow, Russian Federation | |
Moscow City Oncology Hospital #62 | |
Moscow, Russian Federation |
Study Director: | Wendy Cuthbert | Viventia Biotech |
Responsible Party: | Viventia Biotech Inc ( Wendy Cuthbert, Vice President, Clinical Development ) |
Study ID Numbers: | VB6-845-01-I |
Study First Received: | May 31, 2007 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00481936 History of Changes |
Health Authority: | Georgia: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation |
Neoplasms Neoplasm, Epithelial Neoplasm, Glandular |
Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial |