Cancer Clinical Trial
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
| Verified date | January 2021 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 70 |
| Est. completion date | December 18, 2019 |
| Est. primary completion date | December 18, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Imelda Ziekenhuis /ID# 200693 | Bonheiden | |
| Belgium | Cliniques universitaires Saint /ID# 203101 | Brussels | |
| Belgium | UZ Antwerp /ID# 200694 | Edegem | |
| Belgium | UZ Gent /ID# 200691 | Gent | Oost-Vlaanderen |
| Belgium | UZ Leuven /ID# 200001 | Leuven | |
| Canada | Hospital Maisonneuve-Rosemont /ID# 171590 | Montreal | Quebec |
| Canada | Jewish General Hospital /ID# 171584 | Montreal | Quebec |
| Korea, Republic of | National Cancer Center /ID# 170879 | Goyang | Gyeonggido |
| Korea, Republic of | Asan Medical Center /ID# 170877 | Seoul | |
| Korea, Republic of | Samsung Medical Center /ID# 170875 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Seoul National University Hospital /ID# 170878 | Seoul | |
| Spain | Hospital Universitario Vall d'Hebron /ID# 200186 | Barcelona | |
| Spain | Hospital Clinico Universitario San Carlos /ID# 201721 | Madrid | |
| Spain | Hospital General Universitario Gregorio Maranon /ID# 200189 | Madrid | |
| Spain | Hospital Universitario Fundacion Jimenez Diaz /ID# 200187 | Madrid | |
| Spain | Hospital Universitario HM Sanchinarro /ID# 200190 | Madrid | |
| Taiwan | Taichung Veterans General Hosp /ID# 170123 | Taichung City | |
| Taiwan | National Taiwan Univ Hosp /ID# 170677 | Taipei City | Taipei |
| Taiwan | Taipei Veterans General Hosp /ID# 170675 | Taipei City | |
| United States | Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801 | Aurora | Colorado |
| United States | Ironwood Cancer & Res Ctr /ID# 200044 | Chandler | Arizona |
| United States | Cleveland Clinic Main Campus /ID# 200325 | Cleveland | Ohio |
| United States | Fairview Hospital - Moll Pavilion /ID# 205910 | Cleveland | Ohio |
| United States | IACT Health /ID# 169292 | Columbus | Georgia |
| United States | Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112 | Dallas | Texas |
| United States | UTSW-Dallas /ID# 204031 | Dallas | Texas |
| United States | City of Hope /ID# 200501 | Duarte | California |
| United States | Whiteside Institute for Clinic /ID# 200802 | Duluth | Minnesota |
| United States | Duke University Medical Center /ID# 169657 | Durham | North Carolina |
| United States | Virginia Cancer Specialists /ID# 169293 | Fairfax | Virginia |
| United States | Highlands Oncology Group /ID# 169289 | Fayetteville | Arkansas |
| United States | Florida Cancer Specialist - South /ID# 203796 | Fort Myers | Florida |
| United States | Fort Wayne Medical Oncology /ID# 201616 | Fort Wayne | Indiana |
| United States | St. Joseph Heritage Healthcare /ID# 200100 | Fullerton | California |
| United States | Greenville Hospital System /ID# 203021 | Greenville | South Carolina |
| United States | Ingalls Memorial Hosp /ID# 169892 | Harvey | Illinois |
| United States | Millennium Oncology /ID# 204925 | Houston | Texas |
| United States | Kadlec Clinic Hematology and O /ID# 170811 | Kennewick | Washington |
| United States | USC Norris Cancer Center /ID# 200410 | Los Angeles | California |
| United States | Norton Cancer Institute /ID# 200674 | Louisville | Kentucky |
| United States | Univ of Wisconsin Hosp/Clinics /ID# 200424 | Madison | Wisconsin |
| United States | Hillcrest Hospital /ID# 205911 | Mayfield Heights | Ohio |
| United States | Tennessee Oncology, PLLC /ID# 203581 | Nashville | Tennessee |
| United States | Tennessee Oncology-Nashville Centennial /ID# 203424 | Nashville | Tennessee |
| United States | Ochsner Clinic Foundation-New Orleans /ID# 169291 | New Orleans | Louisiana |
| United States | Hoag Memorial Hosp Presbyterian /ID# 202661 | Newport Beach | California |
| United States | INTEGRIS Cancer Institute /ID# 200832 | Oklahoma City | Oklahoma |
| United States | INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831 | Oklahoma City | Oklahoma |
| United States | University of Nebraska /ID# 203195 | Omaha | Nebraska |
| United States | The Valley Hospital /ID# 169999 | Paramus | New Jersey |
| United States | Illinois Cancer Care, PC /ID# 202189 | Peoria | Illinois |
| United States | Thomas Jefferson University /ID# 200833 | Philadelphia | Pennsylvania |
| United States | UPMC Hillman Cancer Ctr /ID# 200672 | Pittsburgh | Pennsylvania |
| United States | Oregon Health and Science University /ID# 170807 | Portland | Oregon |
| United States | Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488 | Redondo Beach | California |
| United States | UC Davis Comprehensive Cancer Center - Main /ID# 207227 | Sacramento | California |
| United States | Washington University School /ID# 200621 | Saint Louis | Missouri |
| United States | Mmcorc /Id# 202099 | Saint Louis Park | Minnesota |
| United States | Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215 | San Luis Obispo | California |
| United States | Central Coast Medical Oncology /ID# 200227 | Santa Maria | California |
| United States | University of California, Los /ID# 169294 | Santa Monica | California |
| United States | Medical Oncology Associates /ID# 169290 | Spokane | Washington |
| United States | Florida Cancer Specialists-Panhandle /ID# 203787 | Tallahassee | Florida |
| United States | Georgetown University Hospital /ID# 202903 | Washington | District of Columbia |
| United States | Cancer Center of Kansas /ID# 200627 | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Belgium, Canada, Korea, Republic of, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | 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 | |
| Secondary | Overall Survival (OS) | OS is defined as the time from randomization until 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 |
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