Study Stopped
Per protocol, the study was terminated based on interim analysis results
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
1 other identifier
interventional
65
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Mar 2009
Typical duration for phase_1 colorectal-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
March 23, 2015
CompletedApril 26, 2024
April 1, 2024
3.3 years
February 4, 2009
March 19, 2014
April 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0
Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months
Study Arms (1)
KRN330 + Irinotecan
EXPERIMENTALopen label, single arm
Interventions
KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyowa Kirin Co., Ltd.lead
- Kyowa Hakko Kirin Pharma, Inc.collaborator
Study Sites (12)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Arizona Clinical Research Center
Tucson, Arizona, 85715, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Lombardi Comprehensive Cancer Center, Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2113, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
University of Florida COllege of Medicine/Shands Cancer Center
Gainesville, Florida, 32610, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
NYU Clinical Trials Office, New York University Cancer Institute
New York, New York, 10016, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Project Leader
- Organization
- KYOWA KIRIN PHARMA
Study Officials
- STUDY DIRECTOR
Michael Kurman, MD
Kyowa Hakko Kirin Pharma, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 6, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2012
Study Completion
October 1, 2012
Last Updated
April 26, 2024
Results First Posted
March 23, 2015
Record last verified: 2024-04