Back to resultsA Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
Primary Purpose
Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Leucovorin
Fluorouracil - bolus
Bevacizumab
Fluorouracil - infusion
ABT-165
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring cancer, colorectal cancer, ABT-165, FOLFIRI, Bevacizumab, bowel cancer, metastatic colorectal cancer, metastatic colorectal
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.
Sites / Locations
- Ironwood Cancer & Res Ctr /ID# 200044
- Highlands Oncology Group /ID# 169289
- City of Hope /ID# 200501
- St. Joseph Heritage Healthcare /ID# 200100
- USC Norris Cancer Center /ID# 200410
- Hoag Memorial Hosp Presbyterian /ID# 202661
- Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488
- UC Davis Comprehensive Cancer Center - Main /ID# 207227
- Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215
- Central Coast Medical Oncology /ID# 200227
- University of California, Los /ID# 169294
- Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801
- Georgetown University Hospital /ID# 202903
- Florida Cancer Specialist - South /ID# 203796
- Florida Cancer Specialists-Panhandle /ID# 203787
- IACT Health /ID# 169292
- Ingalls Memorial Hosp /ID# 169892
- Illinois Cancer Care, PC /ID# 202189
- Fort Wayne Medical Oncology /ID# 201616
- Cancer Center of Kansas /ID# 200627
- Norton Cancer Institute /ID# 200674
- Ochsner Clinic Foundation-New Orleans /ID# 169291
- Whiteside Institute for Clinic /ID# 200802
- Mmcorc /Id# 202099
- Washington University School /ID# 200621
- University of Nebraska /ID# 203195
- The Valley Hospital /ID# 169999
- Duke University Medical Center /ID# 169657
- Fairview Hospital - Moll Pavilion /ID# 205910
- Cleveland Clinic Main Campus /ID# 200325
- Hillcrest Hospital /ID# 205911
- INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831
- INTEGRIS Cancer Institute /ID# 200832
- Oregon Health and Science University /ID# 170807
- Thomas Jefferson University /ID# 200833
- UPMC Hillman Cancer Ctr /ID# 200672
- Greenville Hospital System /ID# 203021
- Tennessee Oncology-Nashville Centennial /ID# 203424
- Tennessee Oncology, PLLC /ID# 203581
- Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112
- UTSW-Dallas /ID# 204031
- Millennium Oncology /ID# 204925
- Virginia Cancer Specialists /ID# 169293
- Kadlec Clinic Hematology and O /ID# 170811
- Medical Oncology Associates /ID# 169290
- Univ of Wisconsin Hosp/Clinics /ID# 200424
- UZ Gent /ID# 200691
- Imelda Ziekenhuis /ID# 200693
- Cliniques universitaires Saint /ID# 203101
- UZ Antwerp /ID# 200694
- UZ Leuven /ID# 200001
- Hospital Maisonneuve-Rosemont /ID# 171590
- Jewish General Hospital /ID# 171584
- National Cancer Center /ID# 170879
- Samsung Medical Center /ID# 170875
- Seoul National University Hospital /ID# 170878
- Asan Medical Center /ID# 170877
- Hospital Universitario Vall d'Hebron /ID# 200186
- Hospital General Universitario Gregorio Maranon /ID# 200189
- Hospital Clinico Universitario San Carlos /ID# 201721
- Hospital Universitario Fundacion Jimenez Diaz /ID# 200187
- Hospital Universitario HM Sanchinarro /ID# 200190
- National Taiwan Univ Hosp /ID# 170677
- Taichung Veterans General Hosp /ID# 170123
- Taipei Veterans General Hosp /ID# 170675
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABT-165 plus FOLFIRI
Bevacizumab plus FOLFIRI
Arm Description
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Overall Survival (OS)
OS is defined as the time from randomization until death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03368859
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Study may continue
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
cancer, colorectal cancer, ABT-165, FOLFIRI, Bevacizumab, bowel cancer, metastatic colorectal cancer, metastatic colorectal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT-165 plus FOLFIRI
Arm Type
Experimental
Arm Description
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Arm Title
Bevacizumab plus FOLFIRI
Arm Type
Active Comparator
Arm Description
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Folinic Acid
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Fluorouracil - bolus
Other Intervention Name(s)
5-FU
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Fluorouracil - infusion
Other Intervention Name(s)
5-FU
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
ABT-165
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Irinotecan hydrochloride
Intervention Description
Intravenous
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.
Time Frame
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 Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Time Frame
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
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization until death from any cause.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer & Res Ctr /ID# 200044
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224-5665
Country
United States
Facility Name
Highlands Oncology Group /ID# 169289
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703-4005
Country
United States
Facility Name
City of Hope /ID# 200501
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
St. Joseph Heritage Healthcare /ID# 200100
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
USC Norris Cancer Center /ID# 200410
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Hoag Memorial Hosp Presbyterian /ID# 202661
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277-3036
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center - Main /ID# 207227
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401-7068
Country
United States
Facility Name
Central Coast Medical Oncology /ID# 200227
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454-5909
Country
United States
Facility Name
University of California, Los /ID# 169294
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Georgetown University Hospital /ID# 202903
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialist - South /ID# 203796
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8108
Country
United States
Facility Name
Florida Cancer Specialists-Panhandle /ID# 203787
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308-5304
Country
United States
Facility Name
IACT Health /ID# 169292
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-8946
Country
United States
Facility Name
Ingalls Memorial Hosp /ID# 169892
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Illinois Cancer Care, PC /ID# 202189
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Fort Wayne Medical Oncology /ID# 201616
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Cancer Center of Kansas /ID# 200627
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Norton Cancer Institute /ID# 200674
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Ochsner Clinic Foundation-New Orleans /ID# 169291
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Whiteside Institute for Clinic /ID# 200802
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mmcorc /Id# 202099
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Washington University School /ID# 200621
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
University of Nebraska /ID# 203195
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
The Valley Hospital /ID# 169999
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Duke University Medical Center /ID# 169657
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Facility Name
Fairview Hospital - Moll Pavilion /ID# 205910
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111-5605
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 200325
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hillcrest Hospital /ID# 205911
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109-3411
Country
United States
Facility Name
INTEGRIS Cancer Institute /ID# 200832
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73142
Country
United States
Facility Name
Oregon Health and Science University /ID# 170807
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University /ID# 200833
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Facility Name
UPMC Hillman Cancer Ctr /ID# 200672
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Greenville Hospital System /ID# 203021
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 203424
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
Tennessee Oncology, PLLC /ID# 203581
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-7709
Country
United States
Facility Name
UTSW-Dallas /ID# 204031
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Millennium Oncology /ID# 204925
City
Houston
State/Province
Texas
ZIP/Postal Code
77090-1243
Country
United States
Facility Name
Virginia Cancer Specialists /ID# 169293
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Kadlec Clinic Hematology and O /ID# 170811
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Medical Oncology Associates /ID# 169290
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Univ of Wisconsin Hosp/Clinics /ID# 200424
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
UZ Gent /ID# 200691
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Imelda Ziekenhuis /ID# 200693
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Cliniques universitaires Saint /ID# 203101
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Antwerp /ID# 200694
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven /ID# 200001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital Maisonneuve-Rosemont /ID# 171590
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Jewish General Hospital /ID# 171584
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
National Cancer Center /ID# 170879
City
Goyang
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 170875
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 170878
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 170877
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hospital Universitario Vall d'Hebron /ID# 200186
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 200189
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 201721
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 200187
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro /ID# 200190
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
National Taiwan Univ Hosp /ID# 170677
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taichung Veterans General Hosp /ID# 170123
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 170675
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
35920133
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.
Results Reference
derived
Learn more about this 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
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