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A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma (mCRC)
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.
Details
| Lead sponsor | Enzon Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 220 |
| Start date | 2009-06 |
| Completion | 2012-01 |
Conditions
- Metastatic Colorectal Cancer
Interventions
- EZN-2208, Cetuximab and Irinotecan
Primary outcomes
- Response Rate — 2011
Countries
United States, Canada, Israel, Netherlands, United Kingdom