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

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00575562
First received: December 14, 2007
Last updated: June 22, 2010
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

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:
    Drug: KRN330
    Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer
    Other Name: KRN330
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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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

No publications provided

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
Study First Received: December 14, 2007
Last Updated: June 22, 2010
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013