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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
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.
Clearview Cancer Institute
Huntsville, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
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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Lombardi Comprehensive Cancer Center, Georgetown University Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
University of Florida COllege of Medicine/Shands Cancer Center
Gainesville, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
NYU Clinical Trials Office, New York University Cancer Institute
New York, New York, United States
...and 2 more locations