A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma
Status:
Unknown status
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
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.