Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal Adenocarcinoma
NCT00102024 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2010-08-27
Summary
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.
Conditions
Interventions
- DRUG
-
Unconjugated IDEC-159
- DRUG
-
111In-IDEC-159
- DRUG
-
90Y-IDEC-159
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Andres Forero, M.D. · Comprehensive Cancer Center, University of Alabama at Birmingham
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Primary Completion
- 2006-01-31
- Completion
- 2006-01-31
Countries
- United States
Study Locations
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