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

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: KRN330

Study type: Interventional

Funder types: Industry

Identifiers

NCT00575562

KRN330-US-01

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)