Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Biological: KRN330 Drug: Irinotecan | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: KRN330 + Irinotecan
open label, single arm
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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. |
- 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 ]

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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.

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): NCT00838578
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 |
Study Director: | Michael Kurman, MD | Kyowa Hakko Kirin Pharma, Inc. |
Responsible Party: | Kyowa Hakko Kirin Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00838578 History of Changes |
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 |
KRN330 Colorectal Cancer Antimetabolites Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Irinotecan Enzyme Inhibitors |
Intestinal Diseases Immunosuppressive Agents Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Fluorouracil Neoplasms Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Irinotecan Antineoplastic Agents Antimetabolites Antibodies, Monoclonal Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |