Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00102024|
Recruitment Status : Terminated
First Posted : January 20, 2005
Last Update Posted : August 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastases||Drug: Unconjugated IDEC-159 Drug: 111In-IDEC-159 Drug: 90Y-IDEC-159||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
- To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.
- To evaluate activity; blood, normal organ, and tumor dosimetry; the immunogenicity and pharmacokinetics of 90Y-IDEC-159; and its effect on soluble TAG-72 (sTAG-72) levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102024
|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|