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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00102024 |
This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal cancer. The objectives of the study are to obtain information on the safety of radiolabeled IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the maximum tolerated dose (MTD). The study duration is 2 years with visits occuring daily and/or weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.
Condition | Intervention | Phase |
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Colorectal Cancer Metastases |
Drug: Unconjugated IDEC-159 Drug: 111In-IDEC-159 Drug: 90Y-IDEC-159 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I/II, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Single Dose 90Y-Labeled IDEC-159, Humanized, Domain Deleted, Anti TAG-72 Monoclonal Antibody, in Subjects With Metastatic Colorectal Adenocarcinoma |
Estimated Enrollment: | 30 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294-3300 |
Principal Investigator: | Andres Forero, M.D. | Comprehensive Cancer Center, University of Alabama at Birmingham |
Study ID Numbers: | 159-01 |
Study First Received: | January 19, 2005 |
Last Updated: | June 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00102024 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Colorectal Adenocarcinoma Anti TAG-72 Monoclonal Antibody |
Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Carcinoma Antibodies, Monoclonal |
Antibodies Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Immunoglobulins Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Carcinoma |
Antibodies, Monoclonal Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |