Back to resultsPhase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KRN330
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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.
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Sites / Locations
- Sarah Cannon Research Institute
- Vanderbilt-Ingram Cancer Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT00575562
First Posted
December 14, 2007
Last Updated
September 19, 2017
Sponsor
Kyowa Kirin, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00575562
Brief Title
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
Official Title
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2007 (Actual)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyowa Kirin, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
KRN330
Intervention Description
Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Berlin, M.D.
Organizational Affiliation
Ingram Professor of Cancer Research, Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Howard A Burris, III, M.D.
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
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