Status:
UNKNOWN
A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma
Lead Sponsor:
Enzon Pharmaceuticals, Inc.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 mu...
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 treatm...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria to be eligible for enrollment in the study.
- Histologically confirmed CRC adenocarcinoma that is metastatic or locally recurrent CRC that is nonresectable
- Patients must agree to genetic testing of the original or metastatic CRC tumor biopsy tissue for K-RAS mutational status.
- Disease progression
- 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.
- No more than 2 prior cytotoxic chemotherapy regimens.
- Age 18 years or older
- Measurable disease by RECIST Version 1.1
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal, and hepatic function
Exclusion
- Patients meeting any of the following exclusion criteria will not be eligible for enrollment.
- Known chronic infectious disease
- Major surgery within 3 weeks before study start
- Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy.
- Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks before the scheduled administration of EZN-2208
- History of other primary cancer within 5 years of enrollment, unless
- Curatively resected non-melanomatous skin cancer, or
- Curatively resected cervical cancer
- 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 cancer
- Any condition such as uncontrollable diabetes, uncontrollable hypertension, or active infection.
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00931840
Start Date
June 1 2009
End Date
January 1 2012
Last Update
September 20 2011
Active Locations (60)
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1
Location #033
Tucson, Arizona, United States, 85724-5024
2
Location# 042
Alhambra, California, United States, 91801
3
Location # 043
Bakersfield, California, United States, 93309
4
Location# 044
Fullerton, California, United States, 92835