NCT00102024

Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal Adenocarcinoma

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Colorectal Cancer
• Metastases

Interventions

Type	Name	Description
DRUG	Unconjugated IDEC-159
DRUG	111In-IDEC-159
DRUG	90Y-IDEC-159

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2005-01-20
• Last updated: 2010-08-27

Locations

1 site across 1 country: United States