Spots Global Cancer Trial Database for Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
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 ID: NCT00838578
Conditions
Study Description
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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Lombardi Comprehensive Cancer Center, Georgetown University Hospital, Washington, 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
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Contact Details
Name: Michael Kurman, MD
Affiliation: Kyowa Hakko Kirin Pharma, Inc.
Role: STUDY_DIRECTOR
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