Metastatic Colorectal Cancer
Conditions
Keywords
EZN-2208 (PEG-SN38)
Brief 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.
Detailed description
EZN-2208 will be administered by i.v. infusion weekly for 3 weeks in 4-week cycles. The cetuximab infusion will be administered before the EZN-2208 (Arm B) or irinotecan (Arm C) infusion. Study treatment will be continued until evidence of disease progression, unacceptable toxicity, or withdrawal of the patient's consent for participation in the study. Approximately 220 patients will be enrolled in this study: approximately 100 patients in the K-RAS mutated arm and approximately 120 patients in the wild-type K-RAS arm.
Interventions
DRUGEZN-2208, Cetuximab and Irinotecan
Patients with mutated K RAS tumors will be treated with single-agent EZN-2208 (Arm A). PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL. Patients with wild-type K-RAS tumors will be randomly assigned in a 2:1 ratio to EZN-2208 + cetuximab (Arm B) or the benchmark of irinotecan + cetuximab (Arm C).
Sponsors
Enzon Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must meet all of the following criteria to be eligible for enrollment in the study. 1. Histologically confirmed CRC adenocarcinoma that is metastatic or locally recurrent CRC that is nonresectable 2. Patients must agree to genetic testing of the original or metastatic CRC tumor biopsy tissue for K-RAS mutational status. 3. Disease progression 4. Previous therapy with irinotecan, oxaliplatin, and fluoropyrimidine either alone or in any combination(s). Patients must have radiographically documented progressive disease while receiving, or within 3 months of receiving, these agents alone or in combination. 5. No more than 2 prior cytotoxic chemotherapy regimens. 6. Age 18 years or older 7. Measurable disease by RECIST Version 1.1 8. ECOG performance status of 0 or 1 9. Adequate bone marrow, renal, and hepatic function
Exclusion criteria
* Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | 2011 |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | 2011 |
Countries
Canada, Israel, Netherlands, United Kingdom, United States
Outcome results
None listed