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A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
2 other identifiers
interventional
70
6 countries
65
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cancer
Started Mar 2018
Shorter than P25 for phase_2 cancer
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedStudy Start
First participant enrolled
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2019
CompletedResults Posted
Study results publicly available
February 9, 2021
CompletedFebruary 9, 2021
January 1, 2021
1.7 years
December 6, 2017
November 17, 2020
January 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.
Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively
Secondary Outcomes (2)
Objective Response Rate (ORR)
From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively
Overall Survival (OS)
Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively
Study Arms (2)
ABT-165 plus FOLFIRI
EXPERIMENTALABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Bevacizumab plus FOLFIRI
ACTIVE COMPARATORBevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Interventions
Intravenous
Intravenous
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (65)
Ironwood Cancer & Res Ctr /ID# 200044
Chandler, Arizona, 85224-5665, United States
Highlands Oncology Group /ID# 169289
Fayetteville, Arkansas, 72703-4005, 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, 90277-3036, 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, 93401-7068, United States
Central Coast Medical Oncology /ID# 200227
Santa Maria, California, 93454-5909, 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 D.C., District of Columbia, 20007, United States
Florida Cancer Specialist - South /ID# 203796
Fort Myers, Florida, 33901-8108, United States
Florida Cancer Specialists-Panhandle /ID# 203787
Tallahassee, Florida, 32308-5304, United States
IACT Health /ID# 169292
Columbus, Georgia, 31904-8946, 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
St 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, 27710-3000, United States
Fairview Hospital - Moll Pavilion /ID# 205910
Cleveland, Ohio, 44111-5605, 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, 73109-3411, 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, 19107-4414, 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, 37203-1632, 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, 75235-7709, United States
UTSW-Dallas /ID# 204031
Dallas, Texas, 75390, United States
Millennium Oncology /ID# 204925
Houston, Texas, 77090-1243, 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, 53792-0001, United States
UZ Gent /ID# 200691
Ghent, 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 2M4, Canada
Jewish General Hospital /ID# 171584
Montreal, Quebec, H3T 1E2, Canada
National Cancer Center /ID# 170879
Goyang, Gyeonggido, 10408, South Korea
Samsung Medical Center /ID# 170875
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Seoul National University Hospital /ID# 170878
Seoul, 03080, South Korea
Asan Medical Center /ID# 170877
Seoul, 05505, South Korea
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, 40705, Taiwan
Taipei Veterans General Hosp /ID# 170675
Taipei, 11217, Taiwan
Related Publications (1)
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.
PMID: 35920133DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2017
First Posted
December 11, 2017
Study Start
March 20, 2018
Primary Completion
December 18, 2019
Study Completion
December 18, 2019
Last Updated
February 9, 2021
Results First Posted
February 9, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.