Trial Search Results
A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma
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.
Stanford is currently not accepting patients for this trial.
Enzon Pharmaceuticals, Inc.
- Drug: EZN-2208, Cetuximab and Irinotecan
- Patients must meet all of the following criteria to be eligible for enrollment in the
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
- Patients meeting any of the following exclusion criteria will not be eligible for
1. Known chronic infectious disease
2. Major surgery within 3 weeks before study start
3. Known or suspected brain metastases requiring intervention with steroids and/or
4. Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy
used to treat the cancer within 3 weeks before the scheduled administration of
5. History of other primary cancer within 5 years of enrollment, unless
1. Curatively resected non-melanomatous skin cancer, or
2. Curatively resected cervical cancer
6. Lack of recovery to Grade 1 from any reversible side effects related to the
administration of an investigational agent, or other prior treatments for the
7. Any condition such as uncontrollable diabetes, uncontrollable hypertension, or
8. Current participation in another clinical study with an investigational agent
and/or use of an investigational drug (not including investigational use of an
approved drug) in the 30 days before the first administration of EZN-2208
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study