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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00575562
First Posted: December 18, 2007
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kyowa Kirin Pharmaceutical Development, Inc.
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Kyowa Kirin Pharmaceutical Development, 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).

Enrollment: 42
Actual Study Start Date: June 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: KRN330
    Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575562


Locations
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development, Inc.
Investigators
Principal Investigator: Jordan Berlin, M.D. Ingram Professor of Cancer Research, Vanderbilt University
Principal Investigator: Howard A Burris, III, M.D. SCRI Development Innovations, LLC
  More Information

Responsible Party: Carolyn Huntenburg,Vice President, Regulatory Affairs, Kirin Pharma USA, Inc
ClinicalTrials.gov Identifier: NCT00575562     History of Changes
Other Study ID Numbers: KRN330-US-01
First Submitted: December 14, 2007
First Posted: December 18, 2007
Last Update Posted: September 20, 2017
Last Verified: December 2007

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs