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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003669-87 | EudraCT Number |
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Study may continue
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-165 plus FOLFIRI | Experimental | ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil). |
|
| Bevacizumab plus FOLFIRI | Active Comparator | Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leucovorin | Drug | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
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:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer & Res Ctr /ID# 200044 | Chandler | Arizona | 85224-5665 | United States | ||
| Highlands Oncology Group /ID# 169289 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35920133 | Derived | 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. |
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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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
A total of 70 participants were randomized to 1 of the 2 study treatments. Participants were grouped according to treatment as randomized.
The intent to treat (ITT) population included all randomized participants and was used for all efficacy and baseline analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-165 Plus FOLFIRI | ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity |
| FG001 | Bevacizumab Plus FOLFIRI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2019 |
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| Fluorouracil - bolus | Drug | Intravenous |
|
|
| Bevacizumab | Drug | Intravenous |
|
|
| Fluorouracil - infusion | Drug | Intravenous |
|
|
| ABT-165 | Drug | Intravenous |
|
| Irinotecan | Drug | Intravenous |
|
|
| 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 |
| 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 |
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABT-165 Plus FOLFIRI | ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity |
| BG001 | Bevacizumab Plus FOLFIRI | Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to Treat (ITT): includes all randomized participants. | Posted | Median | 95% Confidence Interval | Months | 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. | ITT | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | ITT | Posted | Median | 95% Confidence Interval | Months | 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 |
|
|
Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABT-165 Plus FOLFIRI | ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity | 12 | 34 | 17 | 34 | 32 | 34 |
| EG001 | Bevacizumab Plus FOLFIRI | Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity | 6 | 32 | 8 | 32 | 31 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BILE DUCT STENOSIS | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATITIS B | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANAL FISSURE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| TOOTH LOSS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CATHETER SITE PAIN | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Nov 17, 2020 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| C000729544 | ABT-165 |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska native |
|
| Native Hawaiian or other Pacific Islander |
|
| Missing |
|
|
|