Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
NCT ID: NCT00838578
Last Updated: 2024-04-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
65 participants
INTERVENTIONAL
2009-03-31
2012-10-31
Brief Summary
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Detailed Description
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Per protocol, the decision was made to terminate the study based on interim analysis results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when 0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KRN330 + Irinotecan
open label, single arm
KRN330
KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
Irinotecan
Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.
Interventions
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KRN330
KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
Irinotecan
Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Kyowa Hakko Kirin Pharma, Inc.
INDUSTRY
Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Kurman, MD
Role: STUDY_DIRECTOR
Kyowa Hakko Kirin Pharma, Inc.
Locations
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Clearview Cancer Institute
Huntsville, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Lombardi Comprehensive Cancer Center, Georgetown University Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
University of Florida COllege of Medicine/Shands Cancer Center
Gainesville, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
NYU Clinical Trials Office, New York University Cancer Institute
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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KRN330-US-02
Identifier Type: -
Identifier Source: org_study_id
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