A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
- Conditions
- Cancer
- Interventions
- Registration Number
- NCT03368859
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 70
-
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABT-165 plus FOLFIRI ABT-165 ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil). Bevacizumab plus FOLFIRI Fluorouracil - bolus Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil). ABT-165 plus FOLFIRI Fluorouracil - bolus ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil). ABT-165 plus FOLFIRI Fluorouracil - infusion ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil). Bevacizumab plus FOLFIRI Fluorouracil - infusion Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil). ABT-165 plus FOLFIRI Leucovorin ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil). ABT-165 plus FOLFIRI Irinotecan ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil). Bevacizumab plus FOLFIRI Leucovorin Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil). Bevacizumab plus FOLFIRI Bevacizumab Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil). Bevacizumab plus FOLFIRI Irinotecan Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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 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
Name Time Method 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 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) 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 OS is defined as the time from randomization until death from any cause.
Trial Locations
- Locations (65)
USC Norris Cancer Center /ID# 200410
🇺🇸Los Angeles, California, United States
University of California, Los /ID# 169294
🇺🇸Santa Monica, California, United States
Florida Cancer Specialist - South /ID# 203796
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialists-Panhandle /ID# 203787
🇺🇸Tallahassee, Florida, United States
Fairview Hospital - Moll Pavilion /ID# 205910
🇺🇸Cleveland, Ohio, United States
UPMC Hillman Cancer Ctr /ID# 200672
🇺🇸Pittsburgh, Pennsylvania, United States
Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112
🇺🇸Dallas, Texas, United States
Millennium Oncology /ID# 204925
🇺🇸Houston, Texas, United States
Taichung Veterans General Hosp /ID# 170123
🇨🇳Taichung City, Taiwan
Hoag Memorial Hosp Presbyterian /ID# 202661
🇺🇸Newport Beach, California, United States
City of Hope /ID# 200501
🇺🇸Duarte, California, United States
St. Joseph Heritage Healthcare /ID# 200100
🇺🇸Fullerton, California, United States
Highlands Oncology Group /ID# 169289
🇺🇸Fayetteville, Arkansas, United States
Central Coast Medical Oncology /ID# 200227
🇺🇸Santa Maria, California, United States
Ingalls Memorial Hosp /ID# 169892
🇺🇸Harvey, Illinois, United States
Fort Wayne Medical Oncology /ID# 201616
🇺🇸Fort Wayne, Indiana, United States
Ochsner Clinic Foundation-New Orleans /ID# 169291
🇺🇸New Orleans, Louisiana, United States
Illinois Cancer Care, PC /ID# 202189
🇺🇸Peoria, Illinois, United States
Mmcorc /Id# 202099
🇺🇸Saint Louis Park, Minnesota, United States
Cancer Center of Kansas /ID# 200627
🇺🇸Wichita, Kansas, United States
The Valley Hospital /ID# 169999
🇺🇸Paramus, New Jersey, United States
Cleveland Clinic Main Campus /ID# 200325
🇺🇸Cleveland, Ohio, United States
Hillcrest Hospital /ID# 205911
🇺🇸Mayfield Heights, Ohio, United States
Greenville Hospital System /ID# 203021
🇺🇸Greenville, South Carolina, United States
Thomas Jefferson University /ID# 200833
🇺🇸Philadelphia, Pennsylvania, United States
Cliniques universitaires Saint /ID# 203101
🇧🇪Brussels, Belgium
Kadlec Clinic Hematology and O /ID# 170811
🇺🇸Kennewick, Washington, United States
Medical Oncology Associates /ID# 169290
🇺🇸Spokane, Washington, United States
Imelda Ziekenhuis /ID# 200693
🇧🇪Bonheiden, Belgium
UTSW-Dallas /ID# 204031
🇺🇸Dallas, Texas, United States
Virginia Cancer Specialists /ID# 169293
🇺🇸Fairfax, Virginia, United States
UZ Gent /ID# 200691
🇧🇪Gent, Oost-Vlaanderen, Belgium
Univ of Wisconsin Hosp/Clinics /ID# 200424
🇺🇸Madison, Wisconsin, United States
Samsung Medical Center /ID# 170875
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
UZ Antwerp /ID# 200694
🇧🇪Edegem, Belgium
UZ Leuven /ID# 200001
🇧🇪Leuven, Belgium
National Taiwan Univ Hosp /ID# 170677
🇨🇳Taipei City, Taipei, Taiwan
Hospital Universitario Vall d'Hebron /ID# 200186
🇪🇸Barcelona, Spain
Jewish General Hospital /ID# 171584
🇨🇦Montreal, Quebec, Canada
Seoul National University Hospital /ID# 170878
🇰🇷Seoul, Korea, Republic of
Asan Medical Center /ID# 170877
🇰🇷Seoul, Korea, Republic of
Hospital General Universitario Gregorio Maranon /ID# 200189
🇪🇸Madrid, Spain
Taipei Veterans General Hosp /ID# 170675
🇨🇳Taipei City, Taiwan
Duke University Medical Center /ID# 169657
🇺🇸Durham, North Carolina, 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
Tennessee Oncology-Nashville Centennial /ID# 203424
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology, PLLC /ID# 203581
🇺🇸Nashville, Tennessee, United States
Hospital Maisonneuve-Rosemont /ID# 171590
🇨🇦Montreal, Quebec, Canada
Hospital Clinico Universitario San Carlos /ID# 201721
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 200187
🇪🇸Madrid, Spain
UC Davis Comprehensive Cancer Center - Main /ID# 207227
🇺🇸Sacramento, California, United States
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801
🇺🇸Aurora, Colorado, United States
University of Nebraska /ID# 203195
🇺🇸Omaha, Nebraska, United States
Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215
🇺🇸San Luis Obispo, California, United States
Washington University School /ID# 200621
🇺🇸Saint Louis, Missouri, United States
IACT Health /ID# 169292
🇺🇸Columbus, Georgia, United States
Georgetown University Hospital /ID# 202903
🇺🇸Washington, District of Columbia, United States
Whiteside Institute for Clinic /ID# 200802
🇺🇸Duluth, Minnesota, United States
Hospital Universitario HM Sanchinarro /ID# 200190
🇪🇸Madrid, Spain
Ironwood Cancer & Res Ctr /ID# 200044
🇺🇸Chandler, Arizona, United States
Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488
🇺🇸Redondo Beach, California, United States
National Cancer Center /ID# 170879
🇰🇷Goyang, Gyeonggido, Korea, Republic of
Norton Cancer Institute /ID# 200674
🇺🇸Louisville, Kentucky, United States