Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Kirin Pharmaceutical Development, Inc.; Kyowa Kirin, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

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.

-