Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00575562
- Lead Sponsor
- Kyowa Kirin, Inc.
- Brief Summary
The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease.
- Are not candidates for a surgically curative procedure.
- Have progressed despite, are intolerant of, or are not appropriate for current therapies.
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Have an active, uncontrolled infection.
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Have known or suspected cerebral metastasis.
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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).
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Have any significant concurrent disease or illness that would interfere with the interpretation of study results.
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Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer. For up to12 weeks
- Secondary Outcome Measures
Name Time Method The secondary objectives are to determine the degree of immunogenicity, gain information on the pharmacokinetic profile, assess the anti-tumor effects of KRN330 and determine the maximum tolerated dose (MTD). For up to12 weeks
Trial Locations
- Locations (2)
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States