Colon Cancer Clinical Trial
A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
Summary
A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
Primary tumor has been resected > 3 months prior to randomization.
At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting.
Adequate hematologic, renal and hepatic function.
Exclusion Criteria:
Any prior therapy with irinotecan
Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2
Clinically significant conditions that increase the risk for antiangiogenic therapy.
History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
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There are 63 Locations for this study
Chandler Arizona, 85224, United States
Fayetteville Arkansas, 72703, United States
Duarte California, 91010, United States
Fullerton California, 92835, United States
Los Angeles California, 90033, United States
Newport Beach California, 92663, United States
Redondo Beach California, 90277, United States
Sacramento California, 95817, United States
San Luis Obispo California, 93401, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Aurora Colorado, 80014, United States
Washington District of Columbia, 20007, United States
Fort Myers Florida, 33901, United States
Tallahassee Florida, 32308, United States
Columbus Georgia, 31904, United States
Harvey Illinois, 60426, United States
Peoria Illinois, 61615, United States
Fort Wayne Indiana, 46804, United States
Wichita Kansas, 67214, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70121, United States
Duluth Minnesota, 55805, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Missouri, 63108, United States
Omaha Nebraska, 68198, United States
Paramus New Jersey, 07652, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Mayfield Heights Ohio, 44124, United States
Oklahoma City Oklahoma, 73109, United States
Oklahoma City Oklahoma, 73142, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15232, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Houston Texas, 77090, United States
Fairfax Virginia, 22031, United States
Kennewick Washington, 99336, United States
Spokane Washington, 99208, United States
Madison Wisconsin, 53792, United States
Gent Oost-Vlaanderen, 9000, Belgium
Bonheiden , 2820, Belgium
Brussels , 1200, Belgium
Edegem , 2650, Belgium
Leuven , 3000, Belgium
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3T 1, Canada
Goyang Gyeonggido, 10408, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Barcelona , 08035, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Taipei City Taipei, 10002, Taiwan
Taichung City , 40705, Taiwan
Taipei City , 11217, Taiwan
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