Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
Inclusion Criteria:
1. Have histologically confirmed colorectal cancer that is advanced or metastatic with
measurable or assessable disease.
2. Are not candidates for a surgically curative procedure.
3. Have progressed despite, are intolerant of, or are not appropriate for current
therapies.
Exclusion Criteria:
1. Have an active, uncontrolled infection.
2. Have known or suspected cerebral metastasis.
3. 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).
4. Have any significant concurrent disease or illness that would interfere with the
interpretation of study results.
5. Pregnant or breastfeeding women and male or female patients who do not agree to use
effective contraceptive method(s) during the study.
-
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Jordan Berlin, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ingram Professor of Cancer Research, Vanderbilt University
Authority:
United States: Food and Drug Administration
Study ID:
KRN330-US-01
NCT ID:
NCT00575562
Start Date:
June 2007
Completion Date:
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
