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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: KRN330

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

• Sponsor: Kyowa Kirin, 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2007
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: December 14, 2007
• First Submitted That Met QC Criteria: December 14, 2007
• First Posted (ESTIMATE): December 18, 2007

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: KRN330-US-01