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Monoclonal Antibodies

EZN-2208 for Colorectal Cancer

Phase 2
Waitlist Available
Led By Richard M. Goldberg, MD
Research Sponsored by Enzon Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2011
Awards & highlights

Study Summary

This is a Phase 2, multicenter, multiple-arm, open-label study to evaluate the efficacy, safety, and tolerability of EZN-2208. EZN-2208 will be administered as a single agent in patients with K-RAS mutations in the tumors. Patients with wild type K-RAS in tumors will be randomized to EZN-2208 + cetuximab or to standard of care (Camptosar® + cetuximab), patients must have failed regimens containing irinotecan (Camptosar®, CPT-11), oxaliplatin (Eloxatin®), and fluoropyrimidine. After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2011
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2011 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response Rate
Secondary outcome measures
Progression Free Survival (PFS)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: EZN-2208Experimental Treatment1 Intervention
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days. PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL.
Group II: Cetuximab + EZN-2208Experimental Treatment1 Intervention
Cetuximab will be administered as an i.v. infusion on weekly basis. EZN-2208 administered as i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Group III: Irinotecan + cetuximabActive Control1 Intervention
Cetuximab will be administered weekly as an i.v. infusion. Irinotecan will be administered as an i.v. infusion on Weeks 1 and 2 and repeated every 3 weeks.

Find a Location

Who is running the clinical trial?

Enzon Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
1,398 Total Patients Enrolled
Richard M. Goldberg, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
1,803 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby Apr 2025