A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
NCT ID: NCT03368859
Last Updated: 2021-02-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
70 participants
INTERVENTIONAL
2018-03-20
2019-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ABT-165 plus FOLFIRI
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Leucovorin
Intravenous
Fluorouracil - bolus
Intravenous
Fluorouracil - infusion
Intravenous
ABT-165
Intravenous
Irinotecan
Intravenous
Bevacizumab plus FOLFIRI
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Leucovorin
Intravenous
Fluorouracil - bolus
Intravenous
Bevacizumab
Intravenous
Fluorouracil - infusion
Intravenous
Irinotecan
Intravenous
Interventions
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Leucovorin
Intravenous
Fluorouracil - bolus
Intravenous
Bevacizumab
Intravenous
Fluorouracil - infusion
Intravenous
ABT-165
Intravenous
Irinotecan
Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Ironwood Cancer & Res Ctr /ID# 200044
Chandler, Arizona, United States
Highlands Oncology Group /ID# 169289
Fayetteville, Arkansas, United States
City of Hope /ID# 200501
Duarte, California, United States
St. Joseph Heritage Healthcare /ID# 200100
Fullerton, California, United States
USC Norris Cancer Center /ID# 200410
Los Angeles, California, United States
Hoag Memorial Hosp Presbyterian /ID# 202661
Newport Beach, California, United States
Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488
Redondo Beach, California, United States
UC Davis Comprehensive Cancer Center - Main /ID# 207227
Sacramento, California, United States
Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215
San Luis Obispo, California, United States
Central Coast Medical Oncology /ID# 200227
Santa Maria, California, United States
University of California, Los /ID# 169294
Santa Monica, California, United States
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801
Aurora, Colorado, United States
Georgetown University Hospital /ID# 202903
Washington D.C., District of Columbia, United States
Florida Cancer Specialist - South /ID# 203796
Fort Myers, Florida, United States
Florida Cancer Specialists-Panhandle /ID# 203787
Tallahassee, Florida, United States
IACT Health /ID# 169292
Columbus, Georgia, United States
Ingalls Memorial Hosp /ID# 169892
Harvey, Illinois, United States
Illinois Cancer Care, PC /ID# 202189
Peoria, Illinois, United States
Fort Wayne Medical Oncology /ID# 201616
Fort Wayne, Indiana, United States
Cancer Center of Kansas /ID# 200627
Wichita, Kansas, United States
Norton Cancer Institute /ID# 200674
Louisville, Kentucky, United States
Ochsner Clinic Foundation-New Orleans /ID# 169291
New Orleans, Louisiana, United States
Whiteside Institute for Clinic /ID# 200802
Duluth, Minnesota, United States
Mmcorc /Id# 202099
Saint Louis Park, Minnesota, United States
Washington University School /ID# 200621
St Louis, Missouri, United States
University of Nebraska /ID# 203195
Omaha, Nebraska, United States
The Valley Hospital /ID# 169999
Paramus, New Jersey, United States
Duke University Medical Center /ID# 169657
Durham, North Carolina, United States
Fairview Hospital - Moll Pavilion /ID# 205910
Cleveland, Ohio, United States
Cleveland Clinic Main Campus /ID# 200325
Cleveland, Ohio, United States
Hillcrest Hospital /ID# 205911
Mayfield Heights, Ohio, United States
INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831
Oklahoma City, Oklahoma, United States
INTEGRIS Cancer Institute /ID# 200832
Oklahoma City, Oklahoma, United States
Oregon Health and Science University /ID# 170807
Portland, Oregon, United States
Thomas Jefferson University /ID# 200833
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Ctr /ID# 200672
Pittsburgh, Pennsylvania, United States
Greenville Hospital System /ID# 203021
Greenville, South Carolina, United States
Tennessee Oncology-Nashville Centennial /ID# 203424
Nashville, Tennessee, United States
Tennessee Oncology, PLLC /ID# 203581
Nashville, Tennessee, United States
Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112
Dallas, Texas, United States
UTSW-Dallas /ID# 204031
Dallas, Texas, United States
Millennium Oncology /ID# 204925
Houston, Texas, United States
Virginia Cancer Specialists /ID# 169293
Fairfax, Virginia, United States
Kadlec Clinic Hematology and O /ID# 170811
Kennewick, Washington, United States
Medical Oncology Associates /ID# 169290
Spokane, Washington, United States
Univ of Wisconsin Hosp/Clinics /ID# 200424
Madison, Wisconsin, United States
UZ Gent /ID# 200691
Ghent, Oost-Vlaanderen, Belgium
Imelda Ziekenhuis /ID# 200693
Bonheiden, , Belgium
Cliniques universitaires Saint /ID# 203101
Brussels, , Belgium
UZ Antwerp /ID# 200694
Edegem, , Belgium
UZ Leuven /ID# 200001
Leuven, , Belgium
Hospital Maisonneuve-Rosemont /ID# 171590
Montreal, Quebec, Canada
Jewish General Hospital /ID# 171584
Montreal, Quebec, Canada
National Cancer Center /ID# 170879
Goyang, Gyeonggido, South Korea
Samsung Medical Center /ID# 170875
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital /ID# 170878
Seoul, , South Korea
Asan Medical Center /ID# 170877
Seoul, , South Korea
Hospital Universitario Vall d'Hebron /ID# 200186
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 200189
Madrid, , Spain
Hospital Clinico Universitario San Carlos /ID# 201721
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 200187
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 200190
Madrid, , Spain
National Taiwan Univ Hosp /ID# 170677
Taipei City, Taipei, Taiwan
Taichung Veterans General Hosp /ID# 170123
Taichung, , Taiwan
Taipei Veterans General Hosp /ID# 170675
Taipei, , Taiwan
Countries
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References
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Strickler JH, Cubillo A, Liang JT, Matrana M, Kozloff M, Lowe T, Blaney M, Sahtout M, Naumovski L, Wainberg ZA. Efficacy and safety of dilpacimab (ABT-165) versus bevacizumab plus FOLFIRI in metastatic colorectal cancer: a phase II study. Future Oncol. 2022 Sep;18(27):3011-3020. doi: 10.2217/fon-2021-1603. Epub 2022 Aug 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-003669-87
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-064
Identifier Type: -
Identifier Source: org_study_id
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