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.

View Eligibility Criteria

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.

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT03368859

Recruitment Status:

Terminated

Sponsor:

AbbVie

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There are 63 Locations for this study

See Locations Near You

Ironwood Cancer & Res Ctr /ID# 200044
Chandler Arizona, 85224, United States
Highlands Oncology Group /ID# 169289
Fayetteville Arkansas, 72703, United States
City of Hope /ID# 200501
Duarte California, 91010, United States
St. Joseph Heritage Healthcare /ID# 200100
Fullerton California, 92835, United States
USC Norris Cancer Center /ID# 200410
Los Angeles California, 90033, United States
Hoag Memorial Hosp Presbyterian /ID# 202661
Newport Beach California, 92663, United States
Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488
Redondo Beach California, 90277, United States
UC Davis Comprehensive Cancer Center - Main /ID# 207227
Sacramento California, 95817, United States
Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215
San Luis Obispo California, 93401, United States
Central Coast Medical Oncology /ID# 200227
Santa Maria California, 93454, United States
University of California, Los /ID# 169294
Santa Monica California, 90404, United States
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801
Aurora Colorado, 80014, United States
Georgetown University Hospital /ID# 202903
Washington District of Columbia, 20007, United States
Florida Cancer Specialist - South /ID# 203796
Fort Myers Florida, 33901, United States
Florida Cancer Specialists-Panhandle /ID# 203787
Tallahassee Florida, 32308, United States
IACT Health /ID# 169292
Columbus Georgia, 31904, United States
Ingalls Memorial Hosp /ID# 169892
Harvey Illinois, 60426, United States
Illinois Cancer Care, PC /ID# 202189
Peoria Illinois, 61615, United States
Fort Wayne Medical Oncology /ID# 201616
Fort Wayne Indiana, 46804, United States
Cancer Center of Kansas /ID# 200627
Wichita Kansas, 67214, United States
Norton Cancer Institute /ID# 200674
Louisville Kentucky, 40207, United States
Ochsner Clinic Foundation-New Orleans /ID# 169291
New Orleans Louisiana, 70121, United States
Whiteside Institute for Clinic /ID# 200802
Duluth Minnesota, 55805, United States
Mmcorc /Id# 202099
Saint Louis Park Minnesota, 55416, United States
Washington University School /ID# 200621
Saint Louis Missouri, 63108, United States
University of Nebraska /ID# 203195
Omaha Nebraska, 68198, United States
The Valley Hospital /ID# 169999
Paramus New Jersey, 07652, United States
Duke University Medical Center /ID# 169657
Durham North Carolina, 27710, United States
Fairview Hospital - Moll Pavilion /ID# 205910
Cleveland Ohio, 44111, United States
Cleveland Clinic Main Campus /ID# 200325
Cleveland Ohio, 44195, United States
Hillcrest Hospital /ID# 205911
Mayfield Heights Ohio, 44124, United States
INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831
Oklahoma City Oklahoma, 73109, United States
INTEGRIS Cancer Institute /ID# 200832
Oklahoma City Oklahoma, 73142, United States
Oregon Health and Science University /ID# 170807
Portland Oregon, 97239, United States
Thomas Jefferson University /ID# 200833
Philadelphia Pennsylvania, 19107, United States
UPMC Hillman Cancer Ctr /ID# 200672
Pittsburgh Pennsylvania, 15232, United States
Greenville Hospital System /ID# 203021
Greenville South Carolina, 29605, United States
Tennessee Oncology-Nashville Centennial /ID# 203424
Nashville Tennessee, 37203, United States
Tennessee Oncology, PLLC /ID# 203581
Nashville Tennessee, 37203, United States
Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112
Dallas Texas, 75235, United States
UTSW-Dallas /ID# 204031
Dallas Texas, 75390, United States
Millennium Oncology /ID# 204925
Houston Texas, 77090, United States
Virginia Cancer Specialists /ID# 169293
Fairfax Virginia, 22031, United States
Kadlec Clinic Hematology and O /ID# 170811
Kennewick Washington, 99336, United States
Medical Oncology Associates /ID# 169290
Spokane Washington, 99208, United States
Univ of Wisconsin Hosp/Clinics /ID# 200424
Madison Wisconsin, 53792, United States
UZ Gent /ID# 200691
Gent Oost-Vlaanderen, 9000, Belgium
Imelda Ziekenhuis /ID# 200693
Bonheiden , 2820, Belgium
Cliniques universitaires Saint /ID# 203101
Brussels , 1200, Belgium
UZ Antwerp /ID# 200694
Edegem , 2650, Belgium
UZ Leuven /ID# 200001
Leuven , 3000, Belgium
Hospital Maisonneuve-Rosemont /ID# 171590
Montreal Quebec, H1T 2, Canada
Jewish General Hospital /ID# 171584
Montreal Quebec, H3T 1, Canada
National Cancer Center /ID# 170879
Goyang Gyeonggido, 10408, Korea, Republic of
Samsung Medical Center /ID# 170875
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Seoul National University Hospital /ID# 170878
Seoul , 03080, Korea, Republic of
Asan Medical Center /ID# 170877
Seoul , 05505, Korea, Republic of
Hospital Universitario Vall d'Hebron /ID# 200186
Barcelona , 08035, Spain
Hospital General Universitario Gregorio Maranon /ID# 200189
Madrid , 28007, Spain
Hospital Clinico Universitario San Carlos /ID# 201721
Madrid , 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 200187
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro /ID# 200190
Madrid , 28050, Spain
National Taiwan Univ Hosp /ID# 170677
Taipei City Taipei, 10002, Taiwan
Taichung Veterans General Hosp /ID# 170123
Taichung City , 40705, Taiwan
Taipei Veterans General Hosp /ID# 170675
Taipei City , 11217, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT03368859

Recruitment Status:

Terminated

Sponsor:


AbbVie

How clear is this clinincal trial information?

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