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Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

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. Identifier: NCT00838578
Recruitment Status : Terminated (Per protocol, the study was terminated based on interim analysis results)
First Posted : February 6, 2009
Results First Posted : March 23, 2015
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )

Brief Summary:
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: KRN330 Drug: Irinotecan Phase 1 Phase 2

Detailed Description:

Phase II portion is an open-label, single arm study. Based on the results of the Phase I portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the Phase II portion. To be eligible for the Phase II portion, a patient will have recurred or progressed within 6 months of the last cycle of FOLFOX/CapOx +/- bevacizumab (first-line or adjuvant regimen for metastatic colorectal cancer). Patients will continue the treatment until disease progression.

Per protocol, the decision was made to terminate the study based on interim analysis results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when 0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer
Study Start Date : March 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: KRN330 + Irinotecan
open label, single arm
Biological: KRN330
KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.

Drug: Irinotecan
Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.

Primary Outcome Measures :
  1. Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0 [ Time Frame: Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months ]

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.

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

Inclusion Criteria:

  • Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
  • For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.
  • At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
  • Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
  • At least 4 weeks have elapsed since any major surgery.
  • Have ECOG performance status of 0, 1, or 2.
  • Have adequate bone marrow and organ function

Exclusion Criteria:

  • Have an active, uncontrolled infection.
  • Have known HIV positive status.
  • 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 a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).
  • Have a history of greater than or equal to Grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).
  • Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.

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 identifier (NCT number): NCT00838578

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United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, District of Columbia
Lombardi Comprehensive Cancer Center, Georgetown University Hospital
Washington, District of Columbia, United States, 20007-2113
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
University of Florida COllege of Medicine/Shands Cancer Center
Gainesville, Florida, United States, 32610
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, New York
NYU Clinical Trials Office, New York University Cancer Institute
New York, New York, United States, 10016
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
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Study Director: Michael Kurman, MD Kyowa Hakko Kirin Pharma, Inc.
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Responsible Party: Kyowa Hakko Kirin Pharma, Inc. Identifier: NCT00838578    
Other Study ID Numbers: KRN330-US-02
First Posted: February 6, 2009    Key Record Dates
Results First Posted: March 23, 2015
Last Update Posted: November 11, 2015
Last Verified: November 2015
Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. ):
Colorectal Cancer
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Enzyme Inhibitors
Intestinal Diseases
Immunosuppressive Agents
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents