NCT00575562CompletedPhase 1
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kyowa Kirin, Inc.
- Enrollment
- 42
- Locations
- 4
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Have an active, uncontrolled infection.
- •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 any significant concurrent disease or illness that would interfere with the interpretation of study results.
- •Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
Outcomes
Primary Outcomes
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.
Time Frame: For up to12 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (4)
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