Status:
TERMINATED
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Hakko Kirin Pharma, Inc.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxal...
Detailed Description
Phase II portion is an open-label, single arm study. Based on the results of the Phase I portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the Phase II portion. To...
Eligibility Criteria
Inclusion
- Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
- For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.
- At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
- Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
- At least 4 weeks have elapsed since any major surgery.
- Have ECOG performance status of 0, 1, or 2.
- Have adequate bone marrow and organ function
Exclusion
- Have an active, uncontrolled infection.
- Have known HIV positive status.
- Have known or suspected cerebral metastasis.
- Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
- Have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).
- Have a history of greater than or equal to Grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).
- Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00838578
Start Date
March 1 2009
End Date
October 1 2012
Last Update
April 26 2024
Active Locations (12)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
3
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
Lombardi Comprehensive Cancer Center, Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007-2113