Clinical trial NCT03368859: A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Keywords: cancer
colorectal cancer
ABT-165
FOLFIRI
Bevacizumab
bowel cancer
metastatic colorectal cancer
metastatic colorectal
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 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:
measure: Objective Response Rate (ORR)
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: 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
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Res Ctr /ID# 200044
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group /ID# 169289
state: Arkansas
city: Duarte
country: United States
facility: City of Hope /ID# 200501
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare /ID# 200100
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center /ID# 200410
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hosp Presbyterian /ID# 202661
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center - Main /ID# 207227
state: California
city: San Luis Obispo
country: United States
facility: Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology /ID# 200227
state: California
city: Santa Monica
country: United States
facility: University of California, Los /ID# 169294
state: California
city: Aurora
country: United States
facility: Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital /ID# 202903
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialist - South /ID# 203796
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists-Panhandle /ID# 203787
state: Florida
city: Columbus
country: United States
facility: IACT Health /ID# 169292
state: Georgia
city: Harvey
country: United States
facility: Ingalls Memorial Hosp /ID# 169892
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care, PC /ID# 202189
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology /ID# 201616
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas /ID# 200627
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute /ID# 200674
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation-New Orleans /ID# 169291
state: Louisiana
city: Duluth
country: United States
facility: Whiteside Institute for Clinic /ID# 200802
state: Minnesota
city: Saint Louis Park
country: United States
facility: Mmcorc /Id# 202099
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School /ID# 200621
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska /ID# 203195
state: Nebraska
city: Paramus
country: United States
facility: The Valley Hospital /ID# 169999
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center /ID# 169657
state: North Carolina
city: Cleveland
country: United States
facility: Fairview Hospital - Moll Pavilion /ID# 205910
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 200325
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital /ID# 205911
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831
state: Oklahoma
city: Oklahoma City
country: United States
facility: INTEGRIS Cancer Institute /ID# 200832
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 170807
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University /ID# 200833
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Ctr /ID# 200672
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System /ID# 203021
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville Centennial /ID# 203424
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC /ID# 203581
state: Tennessee
city: Dallas
country: United States
facility: Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112
state: Texas
city: Dallas
country: United States
facility: UTSW-Dallas /ID# 204031
state: Texas
city: Houston
country: United States
facility: Millennium Oncology /ID# 204925
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists /ID# 169293
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and O /ID# 170811
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates /ID# 169290
state: Washington
city: Madison
country: United States
facility: Univ of Wisconsin Hosp/Clinics /ID# 200424
state: Wisconsin
city: Gent
country: Belgium
facility: UZ Gent /ID# 200691
state: Oost-Vlaanderen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis /ID# 200693
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint /ID# 203101
city: Edegem
country: Belgium
facility: UZ Antwerp /ID# 200694
city: Leuven
country: Belgium
facility: UZ Leuven /ID# 200001
city: Montreal
country: Canada
facility: Hospital Maisonneuve-Rosemont /ID# 171590
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital /ID# 171584
state: Quebec
city: Goyang
country: Korea, Republic of
facility: National Cancer Center /ID# 170879
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 170875
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 170878
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 170877
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 200186
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 200189
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 201721
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 200187
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 200190
city: Taipei City
country: Taiwan
facility: National Taiwan Univ Hosp /ID# 170677
state: Taipei
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hosp /ID# 170123
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 170675
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.