Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer
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.
The efficacy analysis,based on the intent-to-treat population (44 subjects) was shown to be
4.5%.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate and progression-free survival
Until disease progression post initial KRN330 treatment
No
Michael Kurman, MD
Study Director
Kyowa Hakko Kirin Pharma, Inc.
United States: Food and Drug Administration
KRN330-US-02
NCT00838578
March 2009
October 2012
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Emory University - Winship Cancer Institute | Atlanta, Georgia 30322-1013 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
University of Miami - Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Lombardi Comprehensive Cancer Center, Georgetown University Hospital | Washington, District of Columbia 20007-2113 |
University of Florida COllege of Medicine/Shands Cancer Center | Gainesville, Florida 32610 |
NYU Clinical Trials Office, New York University Cancer Institute | New York, New York 10016 |