Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer - Full Text View

Sponsored by:	Kyowa Hakko Kirin Pharma, Inc.
Information provided by:	Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00575562

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: KRN330	Phase I

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

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).

Estimated Enrollment:	28
Study Start Date:	June 2007

Intervention Details:

Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575562

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Kyowa Hakko Kirin Pharma, Inc.

Investigators

Principal Investigator:	Jordan Berlin, M.D.	Ingram Professor of Cancer Research, Vanderbilt University
Principal Investigator:	Howard A Burris, III, M.D.	Sarah Cannon Research Institute

More Information

Responsible Party:	Kirin Pharma USA, Inc ( Carolyn Huntenburg,Vice President, Regulatory Affairs )
Study ID Numbers:	KRN330-US-01
Study First Received:	December 14, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00575562
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009