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


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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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.

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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 CenterNashville, Tennessee  37232-6838
Sarah Cannon Research InstituteNashville, Tennessee  37203